aqst-20260303
0001398733false00013987332026-03-032026-03-03

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 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 Exhibit 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 Events and Presentations page in the Investors section of 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 Exhibit 99.2) shall not be deemed to be “filed” for purposes of, or otherwise subject to the liabilities of Section 18 of the Exchange Act, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.




Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit NumberDescription
Form of Warrant
Amendment No. 1 to the Purchase and Sale Agreement, dated August 13, 2025, by and between the Company and funds managed by RTW Investments, LP, dated March 3, 2026
Warrant Issuance Agreement, by and between the Company and funds managed by RTW Investments, LP, dated March 3, 2026
Share Purchase Commitment Agreement, by and between the Company and the parties thereto, dated March 3, 2026
Press Release, dated March 4, 2026, announcing the Company’s reported financial results for the quarter and fiscal year ended December 31, 2025 and providing an update on recent developments in its business
Aquestive Therapeutics, Inc. Q4 Earnings Supplemental Materials dated March 4, 2026

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 4, 2026
Aquestive Therapeutics, Inc.
   
 By:/s/ A. Ernest Toth, Jr
  Name: A. Ernest Toth, Jr.
  Title: Chief Financial Officer





Execution Copy NA_DECHERT.95133667.3 COMMON STOCK PURCHASE WARRANT AQUESTIVE THERAPEUTICS, INC. Warrant Shares: _______ Initial Exercise Date: March 3, 2026 Original Issuance Date: March 3, 2026 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [_____________] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after March 3, 2026 (the “Initial Exercise Date”) and on or prior to 5:00 p.m. (New York City time) on March 3, 2029 (the “Termination Date”) but not thereafter, to subscribe for and purchase from Aquestive Therapeutics, Inc., a corporation incorporated under the laws of the state of Delaware (the “Company”), up to ______ shares (as subject to adjustment hereunder, the “Warrant Shares”) of Common Stock. The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b). Section 1. Definitions. Capitalized terms used and not otherwise defined herein shall have the meanings set forth in that certain Warrant Issuance Agreement (the “Purchase Agreement”), dated March 3, 2026, among the Company and the purchasers signatory thereto. Section 2. Exercise. a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company of a duly executed facsimile copy or PDF copy submitted by e-mail (or e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined in Section 2(d)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price for the shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof. 1 For the avoidance of doubt, there is no circumstance that would require the Company to net cash settle the Warrants.


 
NA_DECHERT.95133667.3 b) Exercise Price. The exercise price per share of Common Stock under this Warrant shall be $4.00, subject to adjustment hereunder (the “Exercise Price”). c) Cashless Exercise. Notwithstanding anything to the contrary set forth herein, if at the time of exercise hereof there is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where: (A) = as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the Common Stock on the principal Trading Market as reported by Bloomberg L.P. (“Bloomberg”) as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; (B) = the Exercise Price of this Warrant, as adjusted hereunder; and (X) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being exercised. The Company agrees not to take any position contrary to this Section 2(c). “Bid Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported on The Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Purchasers of a majority in interest of the Securities then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.


 
NA_DECHERT.95133667.3 “VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported on The Pink Open Market (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Purchasers of a majority in interest of the Securities then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company. d) Mechanics of Exercise. i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by Holder or (B) the Warrant Shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144, and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earliest of (i) two (2) Trading Days after the delivery to the Company of the Notice of Exercise, (ii) one (1) Trading Day after delivery of the aggregate Exercise Price to the Company and (iii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise (such date, the “Warrant Share Delivery Date”). Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the Warrant Shares, provided that payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Stock as in effect on the date of delivery of the Notice of Exercise. Notwithstanding the foregoing, with respect to any Notice(s) of Exercise delivered on or prior to 12:00 p.m. (New York City time) on the Initial Exercise Date, which may be delivered at any time after the time of execution of the Purchase Agreement, the Company agrees to deliver the Warrant Shares subject to such notice(s) by 4:00 p.m. (New York City time) on the Initial Exercise Date and the Initial Exercise Date shall be the Warrant Share Delivery Date for purposes hereunder, provided that payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received by such Warrant Share Delivery Date. ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new


 
NA_DECHERT.95133667.3 Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant. iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise. iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of the Warrant as required pursuant to the terms hereof. v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share. vi. Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that, in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares. vii. Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.


 
NA_DECHERT.95133667.3 e) Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. Upon the written or oral request of a Holder, the Company shall within one Trading Day confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict


 
NA_DECHERT.95133667.3 conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant. If the Warrant is unexercisable as a result of the Holder’s Beneficial Ownership Limitation, no alternate consideration is owing to the Holder. Section 3. Certain Adjustments. a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re- classification. b) [RESERVED] c) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, that, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation). d) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in


 
NA_DECHERT.95133667.3 such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution (provided, however, that, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation). e) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company (or any Subsidiary), directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of the Company’s assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding shares of Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, merger or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant and the other Transaction Documents in accordance with the provisions of this Section 3(e) pursuant to written agreements in form and substance reasonably satisfactory to the Holder


 
NA_DECHERT.95133667.3 prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant and the other Transaction Documents referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company herein. f) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding. g) Notice to Holder. i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by facsimile or email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment. ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with a Fundamental Transaction, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by facsimile or email to the Holder at its last facsimile number or email address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger,


 
NA_DECHERT.95133667.3 sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein. h) Voluntary Adjustment By Company. Subject to the rules and regulations of the Trading Market, the Company may at any time during the term of this Warrant reduce the then current Exercise Price to any amount and for any period of time deemed appropriate by the board of directors of the Company. Section 4. Transfer of Warrant. a) Transferability. This Warrant and all rights hereunder (including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date on which the Holder delivers an assignment form to the Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued. b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto. c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary. Section 5. Miscellaneous. a) No Rights as Stockholder Until Exercise; No Settlement in Cash. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except


 
NA_DECHERT.95133667.3 as expressly set forth in Section 3. Without limiting any rights of a Holder to receive Warrant Shares on a “cashless exercise” pursuant to Section 2(c) or to receive cash payments pursuant to Section 2(d)(i) and Section 2(d)(iv) herein, in no event shall the Company be required to net cash settle an exercise of this Warrant. b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate. c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then such action may be taken or such right may be exercised on the next succeeding Trading Day. d) Authorized Shares. The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue). Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant. Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.


 
NA_DECHERT.95133667.3 e) Jurisdiction. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be determined in accordance with the provisions of the Purchase Agreement. f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal securities laws. g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant or the Purchase Agreement, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder. h) Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement. i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company. j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate. k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares. l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company and the Holder. m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant. n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant. ********************


 
NA_DECHERT.95133667.3 (Signature Page Follows)


 
NA_DECHERT.95133667.3 IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated. AQUESTIVE THERAPEUTICS, INC. By: Name: Title:


 
NA_DECHERT.95133667.3 EXHIBIT A NOTICE OF EXERCISE TO: AQUESTIVE THERAPEUTICS, INC. (1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any. (2) Payment shall take the form of (check applicable box): [ ] in lawful money of the United States; or [ ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c). (3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below: The Warrant Shares shall be delivered to the following DWAC Account Number: [SIGNATURE OF HOLDER] Name of Investing Entity: Signature of Authorized Signatory of Investing Entity: Name of Authorized Signatory: Title of Authorized Signatory: Date:


 
NA_DECHERT.95133667.3 EXHIBIT B ASSIGNMENT FORM (To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.) FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to Name: Address: Phone Number: Email Address: Dated: Holder’s Signature: Holder’s Address:


 
Execution Copy AMENDMENT NO. 1 TO PURCHASE AND SALE AGREEMENT This Amendment No. 1 to the Purchase and Sale Agreement (“Amendment”), dated March 3, 2026 (the “Amendment Date”), is between 4010 ROYALTY INVESTMENTS ICAV, AN UMBRELLA IRISH COLLECTIVE ASSET-MANAGEMENT VEHICLE WITH SEGREGATED LIABILITY BETWEEN SUB- FUNDS, FOR AND ON BEHALF OF ITS SUB-FUND, 4010 ROYALTY INVESTMENTS FUND 1 (the “Buyer”), and AQUESTIVE THERAPEUTICS, INC., a corporation incorporated in the State of Delaware (the “Company”), and amends that certain Purchase and Sale Agreement by and between the Buyer and the Company, dated as of August 13, 2025 (as amended, the “Agreement”). WHEREAS, Section 11.5(a) of the Agreement provides that the Agreement may be amended, modified or supplemented only in writing signed by each of the parties to the Agreement. NOW THEREFORE, in consideration of the covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Buyer hereby agree as follows: 1. Defined Terms. Capitalized terms that are used in this Amendment have the meaning set forth in the Agreement, unless otherwise defined in this Amendment. 1. Amendment to Defined Terms. Effective as of the Amendment Date, Section 1.1 of the Agreement is hereby amended by removing the definitions of “Marketing Approval Deadline” and “Transaction Expenses” and replacing each such definition in its entirety as follows: “Marketing Approval Deadline” means 11:59 pm E.T. June 30, 2027. “Transaction Expenses” means the aggregate amount of any and all reasonable and documented out-of-pocket fees and expenses reasonably incurred by or on behalf of, or paid directly by, the Buyer in connection with the transactions contemplated hereby, including diligence and the negotiation, preparation, and execution of the Transaction Documents, and the consummation of the transactions contemplated hereby, subject to a cap of [***].” 2. Expenses. Notwithstanding anything in the contrary set forth in the Agreement, prior to or contemporaneously with the execution of this Amendment, the Seller shall pay the Transaction Expenses incurred prior to or on the Amendment Date. 3. Entire Agreement. The provisions of this Amendment supersede all provisions of the Agreement that are inconsistent with the provisions of this Amendment. The Agreement, as modified by this Amendment, remains in full force and effect and, with the Exhibits annexed thereto and the Disclosure Schedule constitute the entire understanding between the parties hereto with respect to the subject matter hereof and thereof and supersede all other understandings and negotiations with respect hereto and thereto. Unless the context otherwise requires, the term “Agreement” as used in the Agreement shall be deemed to refer to the Agreement as amended hereby.


 
2 4. Miscellaneous. Sections 11.5, 11.7, 11.8, 11.9, 11.10, 11.11, 11.12, 11.13 and 11.14 of the Agreement apply mutatis mutandis to this Amendment [Signature Page Follows]


 
[Signature Page to Amendment No. 1 to Purchase and Sale Agreement] IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. COMPANY AQUESTIVE THERAPEUTICS, INC. By: _/s/ Daniel Barber__________ Name: Daniel Barber Title: Chief Executive Officer and President BUYER 4010 ROYALTY INVESTMENTS ICAV, AN UMBRELLA IRISH COLLECTIVE ASSET-MANAGEMENT VEHICLE WITH SEGREGATED LIABILITY BETWEEN SUB- FUNDS, FOR AND ON BEHALF OF ITS SUB-FUND, 4010 ROYALTY INVESTMENTS FUND 1 By: RTW Investments, LP, its investment manager By: ___/s/ Roderick Wong, M.D._______ Name: Roderick Wong, M.D. Title: Managing Partner


 
Execution Copy WARRANT ISSUANCE AGREEMENT This WARRANT ISSUANCE AGREEMENT (this “Agreement”) is entered into as of March 3, 2026 (the “Effective Date”), between 4010 Royalty Investments ICAV, An Umbrella Irish Collective Asset-Management Vehicle With Segregated Liability Between Sub-Funds, for and on behalf of its Sub-Fund, 4010 Royalty Investments Fund 1 (the “Buyer”), and Aquestive Therapeutics, Inc., a corporation incorporated in the State of Delaware (the “Company”). WHEREAS, the Buyer and the Company are party to that certain Purchase and Sale Agreement, dated August 13, 2025 (the “RTW Agreement”); WHEREAS, on the date hereof, the Company is entering into an amendment to the RTW Agreement (the “RTW Amendment”); WHEREAS, the Company and the Buyer have agreed that, concurrently with execution of the RTW Amendment, on the terms and conditions described in this Agreement, the Company will issue and deliver to the Buyer warrants for the purchase up to 375,000 shares (the “Warrant Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), calculated in accordance with the Warrant attached hereto as Exhibit A (the “Warrant” and together with the Warrant Shares, the “Securities”); and WHEREAS, the parties hereto desire to provide for the subscription and purchase of the Warrants. NOW THEREFORE, in consideration of the covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Buyer hereby agree as follows: 1. Issuance of Warrants. Subject to the terms and conditions of this Agreement, the Company shall issue to the Buyer, on the Effective Date, warrants, in the form of the Warrant, to purchase an aggregate of 375,000 shares of Common Stock on the terms and subject to the conditions set forth in the Warrant in exchange for facilitating the negotiation, execution, delivery and funding of the RTW Amendment substantially concurrently with the execution of this Agreement. 2. Closing. The issuance of the Warrants (the “Closing”) shall take place remotely by electronic transfer of Closing documentation substantially concurrently with the execution of this Agreement. At the Closing, the Company shall deliver to the Buyer the Warrant pursuant to which the Buyer shall have the right to acquire up to such aggregate number of Warrant Shares as is set forth therein, duly executed on behalf of the Company and registered in the name of the Buyer or its designee. 3. Representations and Warranties of the Company. a. Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and otherwise to carry out its respective obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and the consummation by it of the transactions contemplated hereunder have been duly authorized by all necessary action on the part of the Company and no further consent or action is required by the Company, or its Board of Directors or stockholders. The Agreement has been (or upon delivery will have been) duly executed by the Company, and, when delivered in accordance with the terms hereof, will constitute a valid and binding obligation of the Company, enforceable against the Company, in accordance with its terms, except as such enforceability may be limited by general


 
Execution Copy principles of equity or applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally, the enforcement of applicable creditors’ rights and remedies and except as rights to indemnification and to contribution may be limited by federal or state securities law. b. No Conflicts. The execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby (including, without limitation, the reservation of Common Stock for the issuance of the Securities and the subsequent issuance of the Securities) do not and will not (i) conflict with or violate any provision of the Company or any of its subsidiaries’ certificate or articles of incorporation, bylaws or other organizational or charter documents, (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any lien upon any of the properties or assets of the Company or any of its subsidiaries, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing the Company or a the Company subsidiary’s debt or otherwise) or other understanding to which the Company any of its subsidiaries is a party or by which any property or asset of the Company or any of its subsidiaries is bound or affected, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any governmental authority to which the Company or a the Company subsidiary is subject (including, without limitation, foreign, federal and state securities laws and regulations and the rules and regulations of the Nasdaq Stock Market LLC (“Nasdaq”) to which the Company is subject), or by which any property or asset of the Company or a the Company subsidiary is bound or affected; except in the case of clause (ii) or (iii) above, as would not reasonably be expected to (i) have or result in a material adverse effect on the legality, validity, binding effect or enforceability of this Agreement, (ii) have or result in a material adverse effect on the business operations, properties, assets, condition (financial or otherwise) or liabilities of the Company and its subsidiaries, taken as a whole, or (iii) have or result in a material adverse effect on the Company’s authority or ability to perform fully on a timely basis its obligations under this Agreement. c. Consents. Neither the Company nor any of its subsidiaries is required to obtain any consent, waiver, authorization, permit or order of, give any notice to, or make any filing or registration with, any governmental authority or other person in connection with the execution, delivery and performance by the Company of this Agreement, other than (i) the filing of any requisite notices and/or applications(s) to Nasdaq for the issuance and sale of the Warrants and the issuance of the Warrant Shares upon exercise of the Warrants and the listing of the Warrant Shares for trading thereon, and (ii) the filing of a Current Report on Form 8-K, or the disclosure required thereby in another filing, with the Securities and Exchange Commission. The Company is not in violation of any material requirements of the Nasdaq and has no knowledge of any facts or circumstances which would reasonably be expected to result in the delisting or suspension of the Common Stock after the date hereof. d. Issuance of the Securities. The issuance of the Warrants is duly authorized and, upon issuance in accordance with the terms of this Agreement, the Warrants will be validly issued free from all preemptive or similar rights, taxes, liens (other than transfer limitations imposed by applicable securities laws) and charges with respect to the issue thereof. As of the Closing, the Company shall have reserved from its duly authorized capital stock not less than 100% of the maximum number of Warrant Shares issuable upon exercise of the Warrants (without taking into account any limitations on the exercise of the Warrants set forth therein). Upon exercise in accordance with the Warrants, the Warrant Shares when issued, will be validly issued, fully paid and nonassessable and free from all preemptive or similar rights, taxes, liens and charges with respect to the issue thereof, with the holders being


 
Execution Copy entitled to all rights accorded to a holder of Common Stock (as set forth in the applicable charter documents). 4. Representations and Warranties. a. Binding Agreement. This Agreement constitutes the legal, valid and binding obligation of such Buyer, enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by such Buyer does not and will not conflict with, violate or cause a breach of any provision of the organizational documents of such Buyer. b. Accredited Investor Status. Each Buyer is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended (the “Securities Act”). c. Purchase for Own Account. Each Buyer is acquiring, and will acquire, any securities of the Company for its own account, for investment purposes only, and not with a view to, or for offer or sale in connection with, any distribution thereof within the meaning of the Securities Act. 5. Other Agreements of the Parties. a. Register. The Company shall maintain at its principal executive offices (or such other office or agency of the Company as it may designate by notice to each holder of Securities), a register for the Warrants in which the Company shall record the name and address of the person in whose name the Warrants have been issued (including the name and address of each permitted transferee) and the number of Warrant Shares issuable upon exercise of the Warrants held by such person. The Company shall keep the register open and available at all times during business hours upon reasonable notice for inspection of any Buyer or its legal representatives. 6. Miscellaneous: Sections 11.5, 11.7, 11.8, 11.9, 11.10, 11.11, 11.12, 11.13 and 11.14 of the RTW Agreement shall be incorporated mutatis mutandis to this Agreement. [Signature Page Follows]


 
Execution Copy IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. COMPANY AQUESTIVE THERAPEUTICS, INC. By: _/s/ Daniel Barber_________________ Name: Daniel Barber Title: Chief Executive Officer and President BUYER 4010 ROYALTY INVESTMENTS ICAV, AN UMBRELLA IRISH COLLECTIVE ASSET- MANAGEMENT VEHICLE WITH SEGREGATED LIABILITY BETWEEN SUB-FUNDS, FOR AND ON BEHALF OF ITS SUB-FUND, 4010 ROYALTY INVESTMENTS FUND 1 By: RTW Investments, LP, its investment manager By: __/s/ Roderick Wong, M.D.____ ___ Name: Roderick Wong, M.D. Title: Managing Partner


 
Execution Copy EXHIBIT A FORM OF WARRANT 5009875068.2


 
Execution Copy NA_DECHERT.95163257.2 SHARE PURCHASE COMMITMENT AGREEMENT This SHARE PURCHASE COMMITMENT AGREEMENT (this “Agreement”) is entered into as of March 3, 2026 (the “Effective Date”), between each of the purchasers listed on the signature pages hereto (each a “Buyer” and together the “Buyers”), and Aquestive Therapeutics, Inc., a corporation incorporated in the State of Delaware (the “Company”). WHEREAS, an investment vehicle under common management by RTW Investments, LP with the Buyers and the Company are party to that certain Purchase and Sale Agreement, dated August 13, 2025 (the “RTW Agreement”); WHEREAS, on the date hereof, the Company is entering into an amendment to the RTW Agreement (the “RTW Amendment”); and WHEREAS, in connection with the RTW Amendment, the parties hereto desire to set forth certain additional agreements as provided herein. NOW THEREFORE, in consideration of the covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Buyers hereby agree as follows: 1. Purchase Commitment. The Buyers hereby commit and agree that, during the period commencing on the Effective Date and ending on the date that is 90 days following the Effective Date (the “Commitment Period”), the Buyers shall, severally and not joint and severally, purchase from the Company, in one or more transactions (each, a “Purchase”), shares of Common Stock of the Company, par value “$0.001 per share (“Common Stock”), for an aggregate purchase price of not less than $5,000,000 (the “Purchase Commitment” and such shares of Common Stock issuable in connection therewith, the “Securities”). The per-share purchase price in respect of each Purchase shall be determined in accordance with Rule 415(a)(4) under the Securities Act. Each Purchase shall be effected pursuant to an effective Registration Statement (as defined in Section 2(e)), and closing shall not be conditioned upon the negotiation, execution or delivery of any additional purchase or transfer documentation. 2. Representations and Warranties of the Company. a. Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and otherwise to carry out its respective obligations hereunder and thereunder. The execution and delivery by the Company of this Agreement and the consummation by it of the transactions contemplated hereunder have been duly authorized by all necessary action on the part of the Company and no further consent or action is required by the Company, or its Board of Directors or stockholders. The Agreement has been (or upon delivery will have been) duly executed by the Company, and, when delivered in accordance with the terms hereof, will constitute a valid and binding obligation of the Company, enforceable against the Company, in accordance with its terms, except as such enforceability may be limited by general principles of equity or applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally, the enforcement of applicable creditors’ rights and remedies and except as rights to indemnification and to contribution may be limited by federal or state securities law. b. No Conflicts. The execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby (including, without limitation, the reservation of Common Stock for the issuance of the Securities and the subsequent issuance of the Securities) do not and


 
will not (i) conflict with or violate any provision of the Company or any of its subsidiaries’ certificate or articles of incorporation, bylaws or other organizational or charter documents, (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any lien upon any of the properties or assets of the Company or any of its subsidiaries, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing the Company or a the Company subsidiary’s debt or otherwise) or other understanding to which the Company any of its subsidiaries is a party or by which any property or asset of the Company or any of its subsidiaries is bound or affected, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any governmental authority to which the Company or a the Company subsidiary is subject (including, without limitation, foreign, federal and state securities laws and regulations and the rules and regulations of the Nasdaq Stock Market LLC (“Nasdaq”) to which the Company is subject), or by which any property or asset of the Company or a the Company subsidiary is bound or affected; except in the case of clause (ii) or (iii) above, as would not reasonably be expected to (i) have or result in a material adverse effect on the legality, validity, binding effect or enforceability of this Agreement, (ii) have or result in a material adverse effect on the business operations, properties, assets, condition (financial or otherwise) or liabilities of the Company and its subsidiaries, taken as a whole, or (iii) have or result in a material adverse effect on the Company’s authority or ability to perform fully on a timely basis its obligations under this Agreement. c. Consents. Neither the Company nor any of its subsidiaries is required to obtain any consent, waiver, authorization, permit or order of, give any notice to, or make any filing or registration with, any governmental authority or other person in connection with the execution, delivery and performance by the Company of this Agreement, other than the filing of any requisite notices and/or applications(s) to Nasdaq for the issuance and sale of the Securities and the listing of the Securities for trading thereon. The Company is not in violation of any material requirements of the Nasdaq and has no knowledge of any facts or circumstances which would reasonably be expected to result in the delisting or suspension of the Common Stock after the date hereof. d. Issuance of the Securities. The issuance of the Securities is duly authorized and, the Company has reserved from its duly authorized capital stock not less than 100% of the maximum number of Securities reasonably expected to be issuable hereunder. The Securities when issued, will be validly issued, fully paid and nonassessable and free from all preemptive or similar rights, taxes, liens and charges with respect to the issue thereof, with the holders being entitled to all rights accorded to a holder of Common Stock (as set forth in the applicable charter documents). e. Registration. The Securities have been or will be registered under the Securities Act (as defined below), pursuant to an effective registration statement (together with the documents incorporated by reference therein, the “Registration Statement”), and the Company has filed or will make such filings with the Securities and Exchange Commission (the “Commission”) as are required by applicable law in connection with the issuance of the Securities, including, if applicable, a prospectus supplement (together with the applicable base prospectus, the “Prospectus”). The Registration Statement is and, as of the settlement date of the Securities, will be, effective, and no stop order suspending the effectiveness of the Registration Statement has been issued by the Commission and no proceeding for that purpose has been initiated or, to the Company’s knowledge, threatened. The Registration Statement and the Prospectus, as of their respective effective or issue dates and as of the settlement date of the Securities, did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of the Prospectus, in light of the circumstances under


 
which they were made) not misleading. The issuance, sale and delivery of the Securities are being effected in compliance in all material respects with the Securities Act and the rules and regulations of the Commission thereunder. 3. Representations and Warranties of Buyers. a. Binding Agreement. This Agreement constitutes the legal, valid and binding obligation of such Buyer, enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by such Buyer does not and will not conflict with, violate or cause a breach of any provision of the organizational documents of such Buyer. b. Accredited Investor Status. Each Buyer is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended (the “Securities Act”). c. Purchase for Own Account. Each Buyer is acquiring, and will acquire, any securities of the Company for its own account, for investment purposes only, and not with a view to, or for offer or sale in connection with, any distribution thereof within the meaning of the Securities Act. 4. Miscellaneous: Sections 11.5, 11.7, 11.8, 11.9, 11.10, 11.11, 11.12, 11.13 and 11.14 of the RTW Agreement shall be incorporated mutatis mutandis to this Agreement. [Signature Page Follows]


 
[Signature Page to the Share Purchase Commitment Agreement] IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. COMPANY AQUESTIVE THERAPEUTICS, INC. By: _/s/ Daniel Barber_______________ Name: Daniel Barber Title: Chief Executive Officer and President


 
[Signature Page to the Share Purchase Commitment Agreement] IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. BUYER RTW MASTER FUND, LTD. By: __/s/ Darshan Patel_________________ Name: Darshan Patel Title: Director


 
[Signature Page to the Share Purchase Commitment Agreement] IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. BUYER RTW INNOVATION MASTER FUND, LTD. By: ___/s/ Darshan Patel_______________ Name: Darshan Patel Title: Director


 
[Signature Page to the Share Purchase Commitment Agreement] IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written. BUYER RTW BIOTECH OPPORTUNITIES OPERATING LTD. By: RTW Investments, LP, its investment manager By: ____/s/ Roderick Wong, M.D.___________ Name: Roderick Wong, M.D. Title: Managing Partner 5009874956.4


 

Exhibit 99.1

aqstlogo.jpg



Aquestive Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
and Provides Business Update

Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual film NDA in Q3 2026; Type A meeting with FDA expected to occur within 30 days
On track to submit regulatory applications for Anaphylm in Canada and the EU in 2026
Extends revenue sharing agreement with RTW to June 30, 2027
Excluding one-time items, meets 2025 guidance for revenue and non-GAAP adjusted EBITDA loss
Guides to end FY2026 with cash and cash equivalents of $70 million
Company to host investment community conference call on March 5, 2026

Warren, N.J., March 4, 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 reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a progress update on the Company's key 2026 objectives.

"We are well-positioned in 2026 to advance Anaphylm, the first and only oral epinephrine rescue medication, towards approval for patients around the world," said Daniel Barber, President and Chief Executive Officer of Aquestive. "We continue to believe the value proposition will be transformative and ultimately save lives. We are focused on rapidly addressing the human factors focused deficiencies cited by the FDA in their recent Complete Response Letter. Our commercial infrastructure is intact and transferable to our new timeline, the allergy market continues to grow, and patient preference remains strongly in favor of the innovation Anaphylm represents. As recently announced, we have strengthened our leadership with the addition of Dr. Greenhawt, an internationally recognized expert in allergy and immunology, as the Chief Medical Officer of the Company. Additionally, we remain well-positioned financially to launch Anaphylm in the U.S., if approved by the FDA. We've never been more confident in Anaphylm's potential to make a meaningful difference for the allergy community."

Anaphylm™ (dibutepinephrine) Sublingual Film
Anaphylm is a non-device based 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, if approved by the U.S. Food and Drug Administration (FDA).

On January 30, 2026, Aquestive received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for Anaphylm in patients weighing 30 kilograms or more. The CRL identified deficiencies related to human factors validation, including potential challenges associated with pouch opening and film placement, as well as a request for a single pharmacokinetics (PK) study to assess the impact of packaging and labeling modifications. The FDA also provided labeling comments intended to inform the final label, if approved by the FDA.

The CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results submitted as part of the NDA regarding comparability to auto-injectors (such as EpiPen® and Auvi-Q®), such as bracketing, repeat dose, and sustainability, were not questioned. No additional studies beyond the requested human factors validation study and related PK study were identified. The FDA indicated that the human factors and PK studies may be conducted in parallel.

To address the items outlined in the CRL, a new human factors validation study and a PK study are planned. A Type A meeting with the FDA has been requested to discuss the most efficient path forward for resubmission, with the NDA anticipated to be resubmitted in the third quarter of 2026, subject to completion of the required studies and



expected FDA response timelines. The Company plans to request an accelerated review upon resubmission, but no expedited review can be guaranteed.

The Company continues to advance its global expansion strategy for Anaphylm, including ongoing regulatory engagement in Canada and preparatory activities in the European Union. These efforts are intended to support potential future submissions and expand access to the Company’s non-invasive epinephrine therapy globally.

Aquestive will continue to prepare for the launch of Anaphylm, a potentially transformative product for the emergency treatment of severe allergic reactions, including anaphylaxis. The initial focus of the Company's launch preparation is to optimize Anaphylm's market access for patients, if approved by the FDA. Aquestive is also increasing awareness of Anaphylm through the continued execution of its medical affairs strategy, including presenting scientific data at medical forums throughout 2026. The Company remains committed to a successful launch of Anaphylm, if approved by the FDA.

AQST-108 (epinephrine) Topical Gel
AQST-108 is a topical epinephrine prodrug gel product candidate being evaluated for alopecia areata (AA) and other potential dermatologic or localized indications. In December 2025, the Company successfully opened an Investigational New Drug (IND) application for AQST-108 with the FDA and received supportive written feedback for continued development of this product candidate.

An initial first-in-human clinical trial of AQST-108 evaluated topical application and systemic exposure and did not identify any serious or topical adverse events. Building on these results, the Company successfully completed dosing in a second Phase 1 clinical trial in the first quarter of 2026 and the data readout from the study is expected in the second quarter of 2026. The intent of this study is to further characterize the safety, tolerability, and pharmacologic profile of the program and to inform potential future development opportunities, including indication selection.

An estimated 6.7 million people in the United States have been affected by AA. Of those affected, 43% are considered severe. The existing therapies for AA are janus kinase (or JAK) inhibitors. These systemic treatments with known side effects come with a "black box" warning and are expensive for patients. Even with these limitations, the current estimated market opportunity for JAK inhibitors is over One Billion U.S. dollars. Since AQST-108 is topical and there is evidence that it acts at the application site, it may not have systemic side effects. As a result of these conditions, AQST-108, if approved by the FDA as a treatment for AA, has the potential to capture meaningful market share for the treatment of these patients.

The topical formulation of AQST-108 is designed to act locally at the site of application, which may support evaluation in settings where minimizing systemic exposure is desirable. This localized delivery approach provides an opportunity to explore additional value for this product beyond a single indication, while maintaining a disciplined, data-driven development strategy.

Commercial Collaborations
Aquestive continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately 47 million doses in the fourth quarter 2025, compared to approximately 43 million doses in the fourth quarter 2024. The Company continues to manufacture Indivior’s Suboxone® Sublingual Film product and the Company's other global collaborations, including Sympazan® (clobazam) Oral Film product for Assertio Holdings, Inc. in the U.S., Ondif® (Ondansetron) Oral Film product for Hypera Pharma in Brazil and Emylif® (riluzole) Oral Film product by Zambon S.p.A in Europe. Aquestive’s manufacturing business remains steady, with the gradual decline of Suboxone being offset by growth across newer collaborations.

The Company, being a U.S. based manufacturer with intellectual property domiciled in the U.S., confirms that its supply chain currently remains largely unaffected by both implemented and proposed government tariffs, providing continued reliability and stability in production and global distribution for the near term.

Sales of royalty-based products, inclusive of Sympazan® (clobazam) Oral Film for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients two years of age and older, and Azstarys®



(serdexmethylphenidate and dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older, continued to contribute to the Company's revenue in the fourth quarter of 2025.

Libervant® (diazepam) Buccal Film remains tentatively approved until January 2027, the scheduled date of expiration of U.S. market orphan drug exclusivity of an FDA approved product of another company. Aquestive continues to believe that expanding patient access to non-invasive seizure rescue therapies is vital and remains committed to putting Libervant in the hands of patients when granted full approval for U.S. market access by the FDA.

RTW Amendment, Warrant and Share Purchase Agreement
On March 3, 2026, the Company entered into Amendment No. 1 to the Purchase and Sale Agreement, dated August 13, 2025, with funds managed by RTW Investments, LP ("RTW"). The Amendment extends the marketing approval deadline for Anaphylm 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 such funds 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. On March 3, 2026, 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 the then current market price as of the date of such purchase(s), as determined in accordance with Rule 415(a)(4) under the Securities Act of 1933, as amended.

Legal Settlement
In December 2025, Aquestive entered into a confidential legal settlement with Neurelis, Inc. related to a civil tort case filed by Neurelis, Inc. in December 2019. Net of insurance payments and reduced ongoing legal costs, Aquestive expects the cash impact in 2026 of such settlement to be the same as or lower than forecasted prior to the settlement.

Fourth Quarter 2025 Financials
Total revenues increased to $13.0 million in the fourth quarter 2025, from $11.9 million in the fourth quarter 2024. This 10% increase in revenue was primarily driven by increases in manufacture and supply revenue.

Manufacture and supply revenue increased to $12.0 million in the fourth quarter 2025 from $10.7 million in the fourth quarter 2024, primarily due to increases in Suboxone revenues and Ondif revenues.

Research and development (R&D) expenses decreased to $3.2 million in the fourth quarter 2025 from $4.9 million in the fourth quarter 2024. The decrease in R&D expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anaphylm development program and decreases in R&D personnel costs and share-based compensation.

Excluding one-time legal expenses, selling, general and administrative expenses increased to $19.6 million in the fourth quarter 2025 from $16.0 million in the fourth quarter 2024. Including the one-time legal expenses, selling, general and administrative expenses increased to $32.8 million in the fourth quarter 2025 from $16.0 million in the fourth quarter 2024, primarily due to higher legal expenses of approximately $13.6 million, higher commercial spending of approximately $3.7 million in preparation for the planned launch of Anaphylm, higher personnel expenses of approximately $0.8 million, and higher share-based compensation of approximately $0.2 million, partially offset by lower severance expenses of approximately $1.7 million, and lower regulatory and licensing fees of approximately $0.5 million.

Excluding one-time legal expenses, Aquestive’s net loss for the fourth quarter 2025 was $18.7 million, or $0.15 for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million, or $0.19 for both basic and diluted loss per share. Including one-time legal expenses, Aquestive’s net loss for the fourth quarter 2025 was $31.9 million, or $0.26 for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million, or $0.19 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses, and manufacture and supply expenses,



partially offset by decreases in research and development expenses and increases in revenues and interest income and other income, net.

Excluding one-time legal expenses, Non-GAAP adjusted EBITDA loss was $14.1 million in the fourth quarter 2025, compared to Non-GAAP adjusted EBITDA loss of $11.0 million in the fourth quarter 2024. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $10.8 million in the fourth quarter 2025, compared to a Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $6.6 million in the fourth quarter 2024.

Full Year 2025 Financials
Excluding the impact of one-time recognition of deferred revenues during the full year 2024, total revenues decreased by $1.5 million, or 3% to $44.5 million for the full year 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $44.5 million for the full year 2025 from $57.6 million for the full year 2024.

Manufacture and supply revenue increased to $40.2 million for the full year 2025 from $40.0 million for the full year 2024, primarily due to increases in Ondif revenues, partially offset by decreases in Suboxone revenues.

R&D expenses decreased to $17.2 million for the full year 2025 from $20.3 million in the full year 2024. The decrease in R&D expenses was primarily due to lower clinical trial costs associated with the continued advancement of the Anaphylm development program, partially offset by increases in product research expenses as well as R&D personnel costs and share-based compensation.

Excluding one-time legal expenses, selling, general and administrative expenses increased to $66.6 million for the full year 2025 from $50.2 million for the full year 2024. Including one-time legal expenses, selling, general and administrative expenses increased to $79.8 million for the full year 2025 from $50.2 million for the full year 2024. The increase primarily represents higher legal expenses of approximately $14.3 million, higher commercial spending of approximately $9.6 million in preparation for the planned launch of Anaphylm, Anaphylm PDUFA fee of $4.3 million, higher personnel expenses of approximately $1.9 million, higher regulatory expenses related to Anaphylm of approximately $1.0 million, and higher share-based compensation expenses of approximately $0.9 million, partially offset by lower severance expenses of approximately $2.8 million, and lower insurance expenses of approximately $0.6 million.

Excluding one-time legal expenses, Aquestive's net loss for the full year 2025 was $70.6 million, or $0.66 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million, or $0.51 for both basic and diluted loss per share. Including one-time legal expenses, Aquestive's net loss for the full year 2025 was $83.8 million, or $0.78 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million, or $0.51 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses, and manufacture and supply expenses, and decreases in revenues, partially offset by decreases in R&D expenses and increases in interest income and other income, net.

Excluding one-time legal expenses, Aquestive's Non-GAAP adjusted EBITDA loss was $49.7 million for the full year 2025, compared to Non-GAAP adjusted EBITDA loss of $23.0 million for the full year 2024. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $34.4 million for the full year 2025, compared to Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $4.0 million for the full year 2024.

As of December 31, 2025, cash and cash equivalents were $121.2 million.




2026 Outlook

Aquestive is providing its full year 2026 financial outlook. The Company expects:
Guidance
Total revenue (in millions)$46 to $50
Non-GAAP adjusted EBITDA loss (in millions)$35 to $30

Our Non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for Anaphylm, continued pre-commercial infrastructure spending for Anaphylm, clinical trial for AQST-108, and regulatory applications for Anaphylm in Canada and the EU. Current guidance does not include costs associated with the sales and marketing of Anaphylm, if approved by the FDA.

Tomorrow’s Conference Call and Webcast Reminder
The Company will host a conference call at 8:00 a.m. EST on Thursday, March 5, 2026.

In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.

A live webcast of the call will be available on the "Events and Presentations" page of the Investor section of Aquestive’s website: Fourth Quarter 2025 Earnings Call. The webcast will be archived for 30 days.

About Anaphylm™
Anaphylm™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.

About AQST-108
AQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist prodrug product candidate. Aquestive completed a first in human study for AQST-108 without any serious or topical adverse events. AQST-108 is based on Aquestive’s Adrenaverse™ platform which contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites.

About Libervant®
Libervant® (diazepam) buccal film is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA approval for U.S. market access received in April 2024 for Libervant was for these epilepsy patients between two and five years of age. However, the FDA converted this approval to a "tentative approval" due to a recent court ruling finding that the FDA did not have authority to approve Libervant for U.S. market access for patients aged between two and five years due to the existing orphan drug market exclusivity granted by the FDA to an intranasal spray of another company. The FDA granted tentative approval in August 2022 for Libervant for treatment of these epilepsy patients twelve years of age and older. U.S. market access for Libervant patients is currently subject to the expiration of the existing orphan drug market exclusivity of the previously FDA approved drug scheduled to occur in January 2027.

Important Safety Information
Do not give Libervant to your child between the ages of two and five if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma.




What is the most important information I should know about Libervant?

Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
shallow or slowed breathing,
breathing stops (which may lead to the heart stopping),
excessive sleepiness (sedation).

Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child.
Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider.
Give Libervant exactly as your child’s healthcare provider prescribed.
Do not share Libervant with other people.
Keep Libervant in a safe place and away from children.
Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.
Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms.
Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Do not give your child more Libervant than prescribed or give Libervant more often than prescribed.

Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.

Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child.



Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse.

Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500.

Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
new or worse depression
feeling agitated or restless
trouble sleeping (insomnia)
acting aggressive, being angry or violent
other unusual changes in behavior or mood
attempts to commit suicide
new or worse anxiety or irritability
an extreme increase in activity and talking (mania)
new or worse panic attacks
acting on dangerous impulses
Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your child’s healthcare provider as scheduled.
Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes.

What are the possible side effects of Libervant?
The most common side effects of Libervant are sleepiness and headache.
These are not all the possible side effects of Libervant.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA-1088.

For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use.

About Aquestive Therapeutics, Inc.
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The Company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using proprietary, best-in-class technologies like PharmFilm®. Aquestive's AdrenaVerse™ platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. The Company is advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine prodrug) topical gel for various potential dermatological conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn.


Non-GAAP Financial Information
This press release and our webcast earnings call regarding our quarterly financial results contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP adjusted



EBITDA loss, non-GAAP adjusted EBITDA loss excluding one-time legal expenses, non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses, non-GAAP adjusted gross margins, non-GAAP adjusted costs and expenses and other adjusted expense measures, because such measures exclude, as applicable, share-based compensation expense, interest expense, interest expense related to the sale of future revenue, interest income, depreciation, amortization, and income taxes. 

Specifically, the Company adjusts net loss for certain non-cash expenses, including share-based compensation expenses; depreciation and amortization; and interest expense related to the sale of future revenue, interest income and other income, net and income taxes, with a result of adjusted EBITDA loss.  Similarly, manufacture and supply expense, R&D expense, and selling, general and administrative expense were adjusted for certain non-cash expenses of share-based compensation expense and depreciation and amortization. Adjusted EBITDA loss and these non-GAAP expense categories are used as a supplement to the corresponding GAAP measures to provide additional insight regarding the Company’s ongoing operating performance. 

These measures supplement the Company’s financial results prepared in accordance with GAAP. Aquestive management uses these measures to analyze its financial results, and its future manufacture and supply expenses, gross margins, R&D expense and selling, general and administrative expense and to help make managerial decisions. In management’s opinion, these non-GAAP measures provide added transparency into the operating performance of Aquestive and added insight into the effectiveness of our operating strategies and actions. The Company may provide one or more revenue measures adjusted for certain discrete items, such as fees collected on certain licensed products, in order to provide investors added insight into our revenue stream and breakdown, along with providing our GAAP revenue. Such measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and the other non-GAAP measures are also likely calculated in a way that is not comparable to similarly titled measures reported by other companies.


Non-GAAP Outlook
In providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the adjustments which have been applicable in determining non-GAAP Adjusted EBITDA and non-GAAP gross margin for these periods are reflected in the tables below. In providing outlook for non-GAAP gross margin, the Company adjusts for non-cash share-based compensation expense and depreciation and amortization. The Company is providing such outlook only on a non-GAAP basis because the Company is unable to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period such as share-based compensation expense, income tax, amortization, and certain other adjusted items, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results.

Forward-Looking Statement
Certain statements in this press release 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™ (dibutepinephrine) sublingual film through clinical development and approval by the FDA, including our ability to address the concerns raised by the FDA in the CRL dated January 30, 2026, the timing of our resubmission of the NDA and a Type A meeting with the FDA and expedited review for Anaphylm; the advancement and related timing of potential international regulatory filings and marketing authorization of Anaphylm outside of the U.S.; that Anaphylm will be the first and only oral administration of epinephrine, if Anaphylm is approved by the FDA; that the Company’s commercialization plans and programs for Anaphylm will enable the Company to effectively compete in the market, if approved by the FDA; the advancement, growth and related timing of our AdrenaVerse™ pipeline epinephrine prodrug product candidates, including AQST-108 (epinephrine) topical gel, through clinical development and FDA regulatory approval process, including design and timing of clinical studies including those necessary to support the targeted indication of alopecia areata, and potential other treatment indications for AQST-108; market access for Libervant®



(diazepam) buccal film for epilepsy patients experiencing acute repetitive seizures (ARS) upon expiration of orphan drug market exclusivity of an approved FDA product of another company; the future commercial opportunity of Anaphylm and AQST-108 should Anaphylm and AQST-108 be approved by the FDA; the potential benefits our product candidates could bring to patients, including with respect to Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA, and acceptance by patients, prescribers and payors of our product candidates as an alternative to existing standards of care for the targeted medical indication of these product candidates; that the Company is sufficiently capitalized with sufficient cash in 2026 to perform the necessary clinical work and provide the additional information required to address the concerns of the FDA outlined in the CRL; that our supply chain is largely unaffected by implemented and proposed government tariffs and will be reliable and stable in production and global distribution for the near term; our cash requirements, cash funding and cash burn; short-term and longer term liquidity and the ability to fund our business operations; our growth and future financial and operating results and financial position, including with respect to our 2026 financial outlook; and business strategies, market opportunities, and other statements that are not historical facts.

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 our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates Anaphylm, Libervant and AQST-108, or failure to receive FDA approval at all of any or all of these product candidates; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm, Libervant and AQST-108; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm, Libervant and AQST-108; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the CRL for Anaphylm and whether the FDA may request further information from us (including additional clinical studies), disagree with our findings or otherwise undertake a lengthy review of the resubmission of our NDA, and challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product candidates, including Anaphylm, Libervant and AQST-108; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Senior Secured Notes in 2026, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, Libervant and AQST-108, should these product candidates be approved by the FDA; risk of the impact of our obligations under the Company's Purchase Agreement and the Royalty Rights Agreement with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations and the payment of principal and interest on our debt; the risk of our obligations under such Purchase Agreement and Royalty Rights Agreement impacting our ability to refinance our 13.5% Senior Secured Notes; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates in the U.S. and abroad, including Anaphylm and Libervant, if such product candidates should be approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; 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 in the U.S. and abroad of our product candidates, including Anaphylm and Libervant, should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets and expected related revenues and sales; risk associated with our 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 our products; risk that



our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office or, if issued, will be sufficient to provide long-term commercial success of these product candidates; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business, including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of government tariffs and other trade restrictions; and other uncertainties affecting the Company including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those 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 the Company or any person acting on its 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.

PharmFilm®, Libervant®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.
Investor inquiries:
Astr Partners
Brian Korb
[email protected]




AQUESTIVE THERAPEUTICS, INC.
Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)

 December 31,
 20252024
Assets  
Current assets:  
Cash and cash equivalents$121,169 $71,546 
Trade and other receivables, net17,763 7,344 
Inventories, net6,169 6,044 
Prepaid expenses and other current assets4,168 3,286 
Total current assets149,269 88,220 
Property and equipment, net3,893 3,799 
Right-of-use assets, net4,621 5,182 
Other non-current assets2,642 4,223 
Total assets$160,425 $101,424 
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable$29,862 $10,287 
Accrued expenses5,029 5,907 
Lease liabilities, current631 510 
Deferred revenue, current1,092 1,048 
Liability related to the sale of future revenue, current1,000 1,000 
Royalty obligations, current— 87 
Loans payable, current9,994 26 
Total current liabilities47,608 18,865 
Loans payable, net27,519 32,500 
Royalty obligations, net
25,941 20,129 
Liability related to the sale of future revenue, net 62,023 62,718 
Lease liabilities4,337 4,968 
Deferred revenue, net of current portion19,390 20,005 
Other non-current liabilities7,269 2,395 
Total liabilities194,087 161,580 
Contingencies
Stockholders’ deficit:
Common stock, $0.001 par value. Authorized 250,000,000 shares; 122,044,299 and 91,413,742 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively
122 91 
Additional paid-in capital413,214 302,967 
Accumulated deficit(446,998)(363,214)
Total stockholders’ deficit(33,662)(60,156)
Total liabilities and stockholders’ deficit$160,425 $101,424 



AQUESTIVE THERAPEUTICS, INC.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data amounts)
(Unaudited)

  Three Months Ended
December 31,
Year Ended
December 31,
 2025202420252024
Revenues$13,015 $11,867 $44,545 $57,561 
Costs and expenses:
Manufacture and supply5,836 4,520 18,555 17,872 
Research and development3,196 4,917 17,192 20,280 
Selling, general and administrative32,822 16,009 79,849 50,180 
Total costs and expenses41,854 25,446 115,596 88,332 
Loss from operations(28,839)(13,579)(71,051)(30,771)
Other income (expenses):
Interest expense(2,778)(2,779)(11,120)(11,122)
Interest expense related to royalty obligations(1,433)(1,384)(5,737)(5,459)
Interest expense related to the sale of future revenue(62)(61)(243)(236)
Interest income and other income, net1,252 734 4,367 3,437 
Net loss before income taxes(31,860)(17,069)(83,784)(44,151)
Income taxes benefit— 14 — 14 
Net loss$(31,860)$(17,055)$(83,784)$(44,137)
Comprehensive loss$(31,860)$(17,055)$(83,784)$(44,137)
Loss per share attributable to common stockholders:
Basic and diluted (in dollars per share)$(0.26)$(0.19)$(0.78)$(0.51)
Weighted average common shares outstanding:
Basic and diluted (in shares)121,966,911 91,199,407 106,926,528 86,726,211 



AQUESTIVE THERAPEUTICS, INC.
Reconciliation of Non-GAAP Adjustments - Net Loss to Adjusted EBITDA
(In Thousands)
(Unaudited)

 Three Months Ended
December 31,
Year Ended
December 31,
 2025202420252024
GAAP net loss
$(31,860)$(17,055)$(83,784)$(44,137)
Share-based compensation expense1,376 2,403 7,624 7,099 
Interest expense2,778 2,779 11,120 11,122 
Interest expense related to the sale of future revenue62 61 243 236 
Interest expense related to royalty obligations1,433 1,384 5,737 5,459 
Interest income and other income, net(1,252)(734)(4,367)(3,437)
Income taxes benefit— (14)— (14)
Depreciation and amortization129 147 548 718 
Total non-GAAP adjustments$4,526 $6,026 $20,905 $21,183 
Adjusted EBITDA$(27,334)$(11,029)$(62,879)$(22,954)
Excluding one-time legal expenses$(13,200)$— $(13,200)$— 
Adjusted EBITDA excluding one-time legal expenses$(14,134)$(11,029)$(49,679)$(22,954)
Excluding adjusted R&D expenses$(3,355)$(4,474)$(15,256)$(18,995)
Adjusted EBITDA excluding adjusted R&D expenses and one-time legal expenses$(10,779)$(6,555)$(34,423)$(3,959)



AQUESTIVE THERAPEUTICS, INC.
Reconciliation of Non-GAAP Adjustments - Total Costs and Expenses to Adjusted Costs and Expenses
(In Thousands)
(Unaudited)

 Three Months Ended
December 31,
Year Ended
December 31,
 2025202420252024
Total costs and expenses$41,854 $25,446 $115,596 $88,332 
Non-GAAP adjustments:
Share-based compensation expense(1,376)(2,403)(7,624)(7,099)
Depreciation and amortization(129)(147)(548)(718)
Adjusted costs and expenses$40,349 $22,896 $107,424 $80,515 

Manufacture and supply expense$5,836 $4,520 $18,555 $17,872 
Gross Margin on total revenue55 %62 %58 %69 %
Non-GAAP adjustments:
Share-based compensation expense(123)(103)(481)(374)
Depreciation and amortization(103)(124)(442)(606)
Non-GAAP adjusted manufacture and supply expense$5,610 $4,293 $17,632 $16,892 
Non-GAAP Gross Margin on total revenue57 %64 %60 %71 %

Research and development expense$3,196 $4,917 $17,192 $20,280 
Non-GAAP adjustments:
Share-based compensation expense173 (427)(1,875)(1,215)
Depreciation and amortization(14)(16)(61)(70)
Non-GAAP adjusted research and development expense$3,355 $4,474 $15,256 $18,995 

Selling, general and administrative expenses$32,822 $16,009 $79,849 $50,180 
Non-GAAP adjustments:
Share-based compensation expense(1,426)(1,873)(5,268)(5,510)
Depreciation and amortization(12)(7)(45)(42)
Non-GAAP adjusted selling, general and administrative expenses$31,384 $14,129 $74,536 $44,628 

Advancing medicines. Solving problems. Improving lives. September 2024 Fourth Quarter and Full Year 2025 Earnings Supplemental Materials March 4, 2026


 
© 2026 Aquestive Therapeutics, Inc. 2 Disclaimer Certain statements in this press release 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 (dibutepinephrine) sublingual film through clinical development and approval by the FDA, including our ability to address the concerns raised by the FDA in the CRL dated January 30, 2026, the timing of our resubmission of the NDA and a Type A meeting with the FDA and expedited review for Anaphylm; the advancement and related timing of potential international regulatory filings and marketing authorization of Anaphylm outside of the U.S.; that Anaphylm will be the first and only oral administration of epinephrine, if Anaphylm is approved by the FDA; that the Company’s commercialization plans and programs for Anaphylm will enable the Company to effectively compete in the market, if approved by the FDA; the advancement, growth and related timing of our AdrenaVerse pipeline epinephrine prodrug product candidates, including AQST-108 (epinephrine) topical gel, through clinical development and FDA regulatory approval process, including design and timing of clinical studies including those necessary to support the targeted indication of alopecia areata, and potential other treatment indications for AQST-108; that the Company is sufficiently capitalized with sufficient cash in 2026 to perform the necessary clinical work and provide the additional information required to address the concerns of the FDA outlined in the CRL; our cash requirements, cash funding and cash burn; short-term and longer term liquidity and the ability to fund our business operations; our growth and future financial and operating results and financial position, including with respect to our 2026 financial outlook; and business strategies, market opportunities, and other statements that are not historical facts. 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 our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates Anaphylm, Libervant and AQST-108, or failure to receive FDA approval at all of any or all of these product candidates; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm, Libervant and AQST-108; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm, Libervant and AQST-108; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the CRL for Anaphylm and whether the FDA may request further information from us (including additional clinical studies), disagree with our findings or otherwise undertake a lengthy review of the resubmission of our NDA, and challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product candidates, including Anaphylm, Libervant and AQST-108; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Senior Secured Notes in 2026, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, Libervant and AQST-108, should these product candidates be approved by the FDA; risk of the impact of our obligations under the Company's Purchase Agreement and the Royalty Rights Agreement with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations and the payment of principal and interest on our debt; the risk of our obligations under such Purchase Agreement and Royalty Rights Agreement impacting our ability to refinance our 13.5% Senior Secured Notes; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates in the U.S. and abroad, including Anaphylm and Libervant, if such product candidates should be approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; 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 in the U.S. and abroad of our product candidates, including Anaphylm and Libervant, should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets and expected related revenues and sales; risk associated with our 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 our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office or, if issued, will be sufficient to provide long-term commercial success of these product candidates; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business, including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of government tariffs and other trade restrictions; and other uncertainties affecting the Company including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on 10- K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those 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 the Company or any person acting on its 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 presentation whether as a result of new information, future events or otherwise, except as may be required by applicable law. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. PharmFilm®, Libervant® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. The trade name “Anaphylm” for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate, AQST-109. All other registered trademarks referenced herein are the property of their respective owners.


 
3 Q4 and Full Year 2025 Earnings Key Messages Anaphylm (dibutepinephrine) sublingual film for severe allergic reactions, including anaphylaxis • Received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 • CRL was focused on packaging and administration • Continue to focus on global expansion • Preparing for a U.S. launch as soon as possible, if approved by FDA AQST-108 (epinephrine) topical gel and the expansion of AdrenaVerse platform • Opened an Investigational New Drug application for AQST-108 with FDA in Q4 2025 • Completed dosing in Phase 1 study and expect data readout in Q2 2026 Strengthened balance sheet provides needed cash to complete Anaphylm approval and progress Anaphylm ex-US • Ended 2025 with approximately $121 million in cash and cash equivalents


 
Human Factors


 
5 The FDA’s DMEPA Group Oversees Human Factors Submissions1 Commissioner Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Office of Medication Error Prevention and Risk Management Division of Medication Error Prevention and Analysis I & II Division of Medication Error Prevention and Analysis (DMEPA I & DMEPA II) As part of the FDA preapproval process for new drug products, we review proposed proprietary drug names, container labels and other labeling, packaging, product design, and human factors submissions to prevent medication errors. We also review medication error reports submitted to the FDA Adverse Event Reporting System (FAERS) and work collaboratively with the Division of Mitigation Assessment and Medication Error Surveillance to investigate and determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. We also collaborate with external stakeholders, regulators, and researchers to understand the causes of medication errors and the effectiveness of interventions to prevent them, and provide guidance to industry on drug development considerations to prevent medication errors. 1. https://www.fda.gov/about-fda/cder-offices-and-divisions/office-surveillance-and-epidemiology-ose-divisions FDA Organizational Chart


 
6 Human Factors Validation Testing Is Designed To Identify Potential “use errors”1 FDA definition of a use error User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm. Human factors validation testing is conducted to demonstrate that the device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. The testing should be comprehensive in scope, adequately sensitive to capture use errors caused by the design of the user interface and should be performed such that the results can be generalized to actual use. 1. https://www.fda.gov/media/80481/download


 
7 From the Anaphylm CRL, DMEPA Is Concerned About Specific Potential “human use errors”: 1. Difficulty opening the Anaphylm primary pouch 2. Potential for tearing the film while opening the pouch 3. Misplacement of the film on top of the tongue (instead of sublingually) 4. Premature removal of film 5. Improvements to Instructions for Use and other labeling


 
8 We believe we have a pathway to addressing (1) difficulty opening the pouch, (2) potential for tearing the film and (3) misplacement of film Previous Pouch Revised Pouch • 2-step fold and tear replaced with single-motion tear • Tear line re-enforced to reduce potential film tearing • Picture of film placement added to pouch • DMEPA language feedback incorporated onto pouch NDC xxxxx-XXX-xx NDC xxxxx-XXX-xx This proposed packaging design is illustrative of planned packaging based on FDA feedback and not for marketing purposes. This product candidate has not yet been approved for use by the FDA. Clinical performance, safety and use have not been established.


 
9 The remaining items (4) premature removal of film and (5) improvements to instructions for use will be covered through language revisions • Addition of “Do not remove Anaphylm” language • Confirmation via human factors validation study • Availability of practice demonstration strips to allow patients the opportunity to experience the product and flavor ahead of actual emergency use, if Anaphylm is approved by the FDA


 
10 DMEPA also indicated we should “(a)ddress potential tolerability use issues in your resubmission.” • Tolerability “use issues” in the human factors study were limited to 4 individuals (out of 166) in a low-risk, simulated use setting • 1 of the 4 participants noted, unprompted, that he “d[id] not like mint taste, but if I had to save my life, I would stick it there for like 10 minutes” • In a clinical setting, no individuals removed the film during dosing • Resubmission will include overview of tolerability issues associated with currently approved medical device epinephrine products


 
Pharmacokinetics Study


 
12 Given the potential “use errors”, FDA requested an additional pharmacokinetic (PK) study to understand the potential impact to PK under several scenarios The FDA requested 5 scenarios: 1. Chewing the film (both swallowing and no swallowing) 2. Alternate sites (i.e., top of tongue) 3. Self-administered with new instructions 4. Healthcare Provider-administered 5. Existing epinephrine injection product We believe scenarios #1 and #2 are informative and not approvability issues given this is off-label data Scenarios #3, #4, and #5 are repetitive to previous data generated by Aquestive which was in the original NDA submission


 
13 All subjects will be required to receive: • An FDA approved epinephrine injection product • Anaphylm administration by trained study staff Some subjects will also: • Use alternate Anaphylm site administration consistent with the CRL • Self-administer Anaphylm using updated product labeling • Using information from the HF validation study • Only Period 4 will incorporate self-administration Study Size: 48 to 60 Subjects Expected PK Study Design Period 1 Study Day 1 Randomized Anaphylm Administration Period 2 Study Day 2 Injectable Epi Administration Period 3 Study Day 15 Randomized Anaphylm Administration Period 4 Study Day 29 Randomized Anaphylm Administration


 
14 Recently Completed and Upcoming Expected Key Milestones AQST – 108 Q4 2026Q1 2026 Q2 2026 Q3 2026 Anaphlym CRL issued on January 30, 2026 Ex-U.S. Regulatory Filings Complete Phase 1 Clinical Study Type A Meeting with FDA NDA ResubmissionHuman Factors Study Clinical PK Study


 
Fourth Quarter 2025 Results


 
16 Expected to Meet Near-term Milestones with Projected Cash Runway into 2027 $68.7 $60.5 $129.1 $121.2 0 20 40 60 80 100 120 Q1 25 Q2 25 Q3 25 Q4 25 U SD (M illi on s) Ending Cash Balance by Quarter


 
17 33,458 47,953 46,241 45,328 42,516 34,418 43,838 43,032 27,262 37,204 43,801 47,250 0 10,000 20,000 30,000 40,000 50,000 60,000 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 D O SE S SH IP PE D (0 00 ’S ) QUARTER Doses Shipped by Quarter Manufacturing Operations Continue to Generate Cash


 
18 Initial 2026 Guidance as of March 4, 2026 2026 Outlook • Total revenues of approximately $46-50 million • Non-GAAP adjusted EBITDA loss of approximately $35-30 million


 
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