What changed in this filing

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Item 9A. Controls and Procedures

2026-03-04 compared with 2025-03-05 · 285 added, 390 removed, 1113 unchanged (38% of the section changed)

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Other Information .

Our Chief Operating Officer Cassie Jung adopted a written sales plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act (the "Jung Plan") on December 10, 2024 .

The Jung Plan commences on March 11, 2025 and ends on December 31, 2025 .

The maximum number of shares to be sold under the Jung Plan is 108,656 shares;

Chief Operating Officer Cassie Jung adopted a written sales plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act (the "Jung Plan") on November 26, 2025 .

The Jung Plan will commence on March 9, 2026 and ends on December 31, 2026 .

The maximum number of shares to be sold under the Jung Plan is 248,587 shares and no shares have been sold as of the date of this Report;

the actual number of shares sold will be dependent on the satisfaction of certain conditions set forth in the Jung Plan.

Our Chief Medical Officer Carl Kraus adopted a written sales plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act (the "Kraus Plan") on December 12, 2024 .

The Kraus Plan commences on March 17, 2025 and ends on February 27, 2026 .

The maximum number of shares to be sold under the Kraus Plan is 75,000 .

The actual number of shares sold will be dependent on the satisfaction of certain conditions set forth in the Kraus Plan.

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.

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333-225924), as filed on June 27, 2018, and incorporated by reference herein).

Indenture dated July 15, 2019, among Aquestive Therapeutics, Inc., as Issuer, any Guarantor that becomes party thereto and U.S.

Bank National Association, as Trustee and Collateral Agent (filed as Exhibit 4.1 to the Current Report on Form 8-K filed on July 16, 2019, and incorporated by reference herein).

First Supplemental Indenture dated November 3, 2020, among Aquestive Therapeutics, Inc., as Issuer, any Guarantor that becomes party thereto and U.S.

Bank National Association, as Trustee and Collateral Agent (filed as Exhibit 4.3 to the Annual Report on Form 10-K of the Company, as filed on March 9, 2021, and incorporated by reference herein).

Second Supplemental Indenture dated November 20, 2020, among Aquestive Therapeutics, Inc., as Issuer, any Guarantor that becomes party thereto and U.S.

Bank National Association, as Trustee and Collateral Agent (filed as Exhibit 4.4 to the Annual Report on Form 10-K of the Company, as filed on March 9, 2021, and incorporated by reference herein).

Third Supplemental Indenture dated August 6, 2021, among Aquestive Therapeutics, Inc., as Issuer, any Guarantor that becomes party thereto and U.S.

Bank National Association, as Trustee and Collateral Agent (filed as Exhibit 4.1 to the Current Report on Form 8-K of the Company, as filed on August 9, 2021, and incorporated by reference herein).

Fourth Supplemental Indenture dated October 7, 2021, among Aquestive Therapeutics, Inc., as Issuer, any Guarantor that becomes party thereto and U.S.

Bank National Association, as Trustee and Collateral Agent (filed as Exhibit 4.1 to the Current Report on Form 8-K of the Company, as filed on August 8, 2021, and incorporated by reference herein).

Form of 2019 Warrant (filed as Exhibit 4.2 to the Current Report on Form 8-K of the Company, filed on July 16, 2019, and incorporated by reference herein).

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333-225924), as filed on June 27, 2018, and incorporated by reference herein).

Form of Purchase Agreement in connection with the 2019 issuance of 12.5% Senior Secured Notes (filed as Exhibit 10.1 to the Current Report on Form 8-K filed on July 16, 2019, and incorporated by reference herein).

Form of 2020 Purchase Agreement in connection with the 2020 issuance of 12.5% Senior Secured Notes (filed as Exhibit 10.3 to the Annual Report of Form 10-K of the Company, as filed on March 9, 2021, and incorporated by reference herein).

Collateral Agreement in connection with issuance of 12.5% Senior Secured Notes, dated as of July 15, 2019, among Aquestive Therapeutics, Inc., as Issuer, the Other Grantors from time to time party thereto, U.S.

Bank National Association, as Trustee, and U.S.

Bank National Association, as Collateral Agent (filed as Exhibit 10.2 to the Current Report on Form 8-K of the Company, as filed on July 16, 2019, and incorporated by reference herein).

Executive Employment Agreement, dated as of July 15, 2022, by and between Aquestive Therapeutics, Inc.

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and MAM Pangolin Royalty, LLC (filed as Exhibit 10.23 to the Annual Report on Form 10-K of the Company, as filed on March 9, 2021, and incorporated by reference herein).

Amendment No.1 to Purchase Agreement, dated as of August 6, 2021, by and between Aquestive Therapeutics, Inc.

and the Purchasers signatory thereto (as filed as Exhibit 10.22 to the Annual Report on Form 10-K of the Company, as filed on March 31, 2021, and incorporated by reference herein).

Amendment No.

2 to Purchase Agreement, dated as of May 13, 2022, by and between Aquestive Therapeutics, Inc.

and the Purchasers signatory thereto (as filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on May 17, 2022, and incorporated by reference herein).

Consent Fee Letter, dated October 7, 2021, among Aquestive Therapeutics, Inc.

and the Noteholder parties thereto (filed as Exhibit 10.1 to the Current Report on Form 8-K filed on October 8, 2021, and incorporated by reference herein).

First Amendment to Executive Employment Agreement, dated as of June 30, 2021, by and between Aquestive Therapeutics, Inc.

and Alexander Mark Schobel (as filed as Exhibit 10.25 to the Annual Report on Form 10-K of the Company, as filed on March 8, 2022, and incorporated by reference herein).

First Amendment to Executive Employment Agreement, dated as of June 30, 2021, by and between Aquestive Therapeutics, Inc.

Kendall (as filed as Exhibit 10.26 to the Annual Report on Form 10-K of the Company, as filed on March 8, 2022, and incorporated by reference herein).

License and Supply Agreement, dated as of September 26, 2022, by and between Aquestive Therapeutics, Inc.

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and Otter Pharmaceuticals, LLC (filed herewith) (as filed as Exhibit 10.29 to the Annual Report on Form 10-K of the Company, as filed on March 31, 2023, and incorporated by reference herein).

Separation Agreement, dated as of May 17, 2022, by and between Aquestive Therapeutics, Inc.

Kendall (filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on May 17, 2022, and incorporated by reference herein).

Form of Securities Purchase Agreement, dated as of June 6, 2022, by and between Aquestive Therapeutics, Inc.

and the purchasers (filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on June 8, 2022, and incorporated by reference herein).

Purchase Agreement, dated as of April 12, 2022, by and between the Company and Lincoln Park (filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on April 13, 2022, and incorporated by reference herein).

Registration Rights Agreement, dated as of April 12, 2022, by and between the Company and Lincoln Park (filed as Exhibit 10.2 to the Current Report on Form 8-K of the Company, as filed on April 13, 2022, and incorporated by reference herein).

Equity Distribution Agreement, dated September 11, 2019, by and between Aquestive Therapeutics, Inc.

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Amendment to License and Supply Agreement between Aquestive and Atnahs Pharma UK Limited entered into March 27, 2023 (filed as Exhibit 10.40 to the Annual Report on Form 10-K of the Company, as filed on March 5, 2024, and incorporated by reference herein).

Insider Trading Policy.

Purchase and Sale Agreement by and between Aquestive Therapeutics, Inc.

and RTW Investments, LP, dated as of August 13, 2025 (filed as Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company, as filed on November 5, 2025, and incorporated by reference herein).

Form of Warrant (filed as Exhibit 4.1 to the Current Report on Form 8-K of the Company, as filed on March 4, 2026, and incorporated by reference herein).

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 (filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on March 4, 2026, and incorporated by reference herein).

Warrant Issuance Agreement, by and between the Company and funds managed by RTW Investments, LP, dated March 3, 2026 (filed as Exhibit 10.2 to the Current Report on Form 8-K of the Company, as filed on March 4, 2026, and incorporated by reference herein).

Share Purchase Commitment Agreement, by and between the Company and the parties thereto, dated March 3, 2026 (filed as Exhibit 10.3 to the Current Report on Form 8-K of the Company, as filed on March 4, 2026, and incorporated by reference herein).

Insider Trading Policy (filed herewith).

Consent of KPMG LLP, Independent Registered Public Accounting Firm (filed herewith).

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Right-of-use assets, net 4,621 5,182

Intangible assets, net — 1,278

Other non-current assets 2,642 4,223

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Interest expense ( 11,120 ) ( 11,122 )

Interest expense related to royalty obligations, net

( 5,459 ) ( 905 )

Interest expense related to royalty obligations ( 5,737 ) ( 5,459 )

Interest expense related to the sale of future revenue ( 243 ) ( 236 )

Interest income and other income, net 4,367 3,437

Loss on the extinguishment of debt — ( 1,382 )

Net loss before income taxes ( 83,784 ) ( 44,151 )

Income taxes benefit (expense)

Income taxes benefit — 14

Net loss $ ( 83,784 ) $ ( 44,137 )

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Balance at December 31, 2023 68,533,085 $ 69 $ 212,521 $ ( 319,077 ) $ ( 106,487 )

54,827,734 $ 55 $ 192,598 $ ( 311,207 ) $ ( 118,554 )

Common Stock issued upon warrant exercises 8,689,452 9 8,333 — 8,342

Costs of common stock issued under private equity offering — — ( 35 ) — ( 35 )

Common Stock issued under public equity offering-ATM 4,557,220 4 12,381 — 12,385

Costs of common stock issued under public equity offering-ATM — — ( 602 ) — ( 602 )

Common Stock issued under public equity offering 17,226,468 18 77,502 — 77,520

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— — ( 5,546 ) — ( 5,546 )

Shares issued under employee stock purchase plan 36,168 — 66 — 66

Vested restricted stock units, net

Common Stock issued upon warrant exercises

30,645 — 165 — 165

Shares issued under employee stock purchase plan 35,374 — 109 — 109

Share-based compensation expense — — 7,056 — 7,056

Vested restricted stock units, net 673,925 — ( 1,351 ) — ( 1,351 )

Options exercised, net

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Adjustments to reconcile net loss to net cash used for operating activities:

Depreciation, amortization, and impairment 718 1,345

Depreciation and amortization 548 718

Share-based compensation 7,624 7,099

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Gain on contract termination

Loss on the extinguishment of debt — 1,029

Other, net 1 104

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Proceeds from issuance of common stock under public equity offering-ATM, net

21,194 11,783

Proceeds from common stock issued under public equity offering, net

79,460 71,974

Proceeds from exercise of warrants, net

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Proceeds from exercise of stock options 1,270 732

Proceeds from issuance of debt — 31,144

Proceeds from issuance of Royalty Rights Agreements

Repayment of debt principal including lease liabilities ( 26 ) ( 23 )

( 23 ) ( 51,529 )

Payments for royalty obligations

Payments for financing costs — ( 4,643 )

Premium paid to retire debt — ( 2,102 )

Payments for taxes on share-based compensation ( 810 ) ( 1,101 )

Net cash provided by financing activities 102,617 83,592

Net increase (decrease) in cash and cash equivalents

47,674 ( 3,401 )

Net increase in cash and cash equivalents 49,623 47,674

Cash and cash equivalents:

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Cash payments for income taxes

Cash refunds received for income taxes $ ( 65 ) $ —

Non-cash investing activities:

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Company Overview and Equity Transactions

Company Overview

(A) Company Overview

Aquestive Therapeutics, Inc.

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The Company is developing pharmaceutical products to deliver complex molecules through alternative administrations to invasive and inconvenient standard of care therapies.

The Company has a proprietary commercial product, Libervant® (diazepam) Buccal Film 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 between two and five years of age, which was launched in April 2024.

The Company is also advancing a product pipeline for the treatment of severe allergic reactions, including anaphylaxis, under the Anaphylm™ trade name, and its Adrenaverse™ epinephrine prodrug pipeline platform.

The Company has five licensed commercialized products which are marketed by its licensees in the U.S.

The Company is advancing a late stage non-device based epinephrine prodrug product candidate for the treatment of severe allergic reactions, including anaphylaxis, under the Anaphylm™ trade name, and its AdrenaVerse™ epinephrine prodrug pipeline platform.

The Company has four licensed commercialized products which are marketed by its licensees in the U.S.

and around the world.

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The Company’s production facilities are located in Portage, Indiana, and its corporate headquarters and primary research laboratory facilities are based in Warren, New Jersey.

Equity Transactions

Equity Offering of Common Stock

(B) Equity Transactions

The Company established its first ATM facility in September 2019, and since inception to December 31, 2025, the Company has sold 27,315,145 shares of Common Stock under its ATM Facility which has generated net cash proceeds of approximately $ 81,753 , net of commissions and other transactions costs of $ 3,890 .

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The remaining authorized balance of the ATM facility was $ 78,000 as of December 31, 2025.

On April 12, 2022, the Company entered into the Lincoln Park Purchase Agreement, which provides that, upon the terms and subject to the conditions and limitations set forth in the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $ 40,000 worth of shares of Common Stock from time to time over the 36-month term of the Lincoln Park Purchase Agreement.

The Lincoln Park Purchase Agreement contains an ownership limitation such that the Company will not issue, and Lincoln Park will not purchase, shares of Common Stock if it would result in Lincoln Park’s beneficial ownership exceeding 9.99 % of the Company's then outstanding Common Stock.

Lincoln Park has covenanted under the Lincoln Park Purchase Agreement not to cause or engage in any manner whatsoever any direct or indirect short selling or hedging of our Common Stock.

For the years ended December 31, 2024 and 2023, the Company did not sell shares in connection with the Lincoln Park Purchase Agreement.

The Company has no current intent to use the Lincoln Park facility and the Lincoln Park Purchase agreement will expire on April 12, 2025.

On March 22, 2024, the Company completed the underwritten public offering of 16,666,667 shares of its common stock at the public offering price of $ 4.50 per share.

Underwritten Public Offerings

On March 22, 2024, the Company completed an underwritten public offering of 16,666,667 shares of its common stock at the public offering price of $ 4.50 per share.

In addition, pursuant to the partial exercise of the underwriters' option, on April 22, 2024, the Company sold an additional 559,801 shares of Common Stock.

Net proceeds from the 2024 Underwritten Public Offering, including the exercise of underwriters' option were $ 72,868 , after deducting underwriting discounts of $ 4,651 .

In addition to the underwriting discounts related to this offering, the Company incurred professional fees and other costs totaling $ 894 as of December 31, 2024.

In addition to the underwriting discounts related to this offering, the Company incurred professional fees and other costs totaling $ 894 .

On August 14, 2025, the Company completed an underwritten public offering of 21,250,000 shares of its common stock at the public offering price of $ 4.00 per share.

Net proceeds from the 2025 Underwritten Public Offering were $ 79,900 , after deducting underwriting discounts of $ 5,100 .

In addition to the underwriting discounts related to this offering, the Company incurred professional fees and other costs totaling $ 440 .

Basis of Presentation and Principles of Consolidation

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As of March 31, 2024, the Company dissolved its subsidiaries and no longer prepares its financial statements on a consolidated basis.

The dissolution of the subsidiaries did not have a material impact on the Company’s financial statements as of December 31, 2024 or the consolidated financial statements as of December 31, 2023.

The dissolution of the subsidiaries did not have a material impact on the Company’s financial statements as of December 31, 2025 and 2024.

Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and ASU of FASB.

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GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

These estimates and assumptions often involve assessments of matters that are inherently uncertain and accordingly actual results could differ from those estimates.

Significant items subject to estimates and assumptions include those related to revenue recognition, inventory costs, allowances for rebates from proprietary product sales of Libervant for patients between two to five years of age, allowances for sales returns, the useful lives of fixed assets and the valuations of warrants issued, royalty obligations, sale of future revenues, share-based compensation, and contingencies.

estimates and assumptions often involve assessments of matters that are inherently uncertain and accordingly actual results could differ from those estimates.

Significant items subject to estimates and assumptions include those related to revenue recognition, inventory costs, allowances for rebates from proprietary product sales of Libervant for patients between two to five years of age, allowances for sales returns, the useful lives of fixed assets and the valuations of royalty obligations, sale of future revenues, share-based compensation, and contingencies.

Cash and Cash Equivalents

The Company considers all short-term, highly liquid investments purchased with original maturities of three months or less to be cash equivalents.

At December 31, 2024 and 2023, cash and cash equivalents consisted of cash in bank accounts and money market Treasury mutual funds.

At December 31, 2025 and 2024, cash and cash equivalents consisted of cash in bank accounts, Treasury bills and money market Treasury mutual funds.

Concentration of Credit Risk

Cash and cash equivalents are held by federally insured financial institutions that management believes are of high credit quality.

Cash and cash equivalents are held and managed by multiple financial institutions that management believes are of high credit quality.

The Company has not experienced any losses in such accounts and such amounts may exceed federally-insured limits of $250.

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On an ongoing basis, management evaluates the adequacy of these reserves.

The allowance for credit losses, was $ 0 and $ 14 as of December 31, 2024 and 2023, respectively.

The allowance for credit losses was $ 0 as of December 31, 2025 and 2024.

Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost, determined by the first-in, first-out method, or net realizable value.

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To the extent that management determines there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products, or use them in production, prior to their expiration, the Company records allowances to adjust the carrying value to estimated net realizable value as necessary.

The Company expenses inventory related to the Company’s research and development activities when the Company purchases or manufactures it.

Before the regulatory approval of the Company’s product candidates, the Company recognizes research and development expense for the manufacture of drug products that could potentially be available to support the commercial launch of the Company’s drug candidates, if approved by regulatory authorities.

The Company expenses inventory related to the Company’s R&D activities when the Company purchases or manufactures it.

Before the regulatory approval of the Company’s product candidates, the Company recognizes R&D expense for the manufacture of drug products that could potentially be available to support the commercial launch of the Company’s drug candidates, if approved by regulatory authorities.

Property and Equipment

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The Company amortized these assets using the straight-line method over the shorter of their legal lives or estimated useful lives.

As of December 31, 2024, the balance of the Company's intangible assets was zero , see Note 12, Intangible Assets, Net for additional information.

As of December 31, 2025 and 2024, the balance of the Company's intangible assets was zero , see Note 12, Intangible Assets, Net for additional information.

Impairment of Long-Lived Assets

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Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered most appropriate.

No impairment was recognized for the year ended December 31, 2024.

The impairment charge of $ 216 was recognized for the year ended December 31, 2023.

No impairment was recognized for the years ended December 31, 2025 and 2024.

Determination if an arrangement is a lease is made at inception.

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Short-term leases, or leases that have a lease term of 12 months or less at consummation date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease.

During the year ended December 31, 2023, the Company recognized a lease supporting its manufacturing facilities as a finance lease.

Commitments under finance leases are not significant, and are included in Property and equipment, net;

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The fair value of the royalty obligation is being amortized over the life of the Royalty Rights Agreements and such amortization is reflected as interest expense related to royalty obligations in the Statements of Operations and Comprehensive Loss.

The 13.5 % Notes are discussed in Note 15, Long-Term Debt , to its financial statements.

The 13.5 % Notes are discussed in Note 15, Long-Term Debt.

Liability Related to the Sale of Future Revenue

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Revenue Recognition

The Company’s revenues include (i) sales of manufactured products pursuant to contracts with commercialization licensees, (ii) license and royalty revenues, (iii) co-development and research fees generally in the form of milestone payments, and (iv) sales of its proprietary CNS product, Libervant, for patients between two to five years of age.

See Note 6, Revenues and Trade Receivables, Net for further details.

market access through April 2025.

The Company recognizes revenue to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.

To achieve this core principle, a five-step model is applied that includes (1) identifying the contract with a customer, (2) identifying the performance obligation in the contract, (3) determining the transaction price, (4) allocating the transaction price to the performance obligations, and (5) recognizing when, or as, an entity satisfies a performance obligation.

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in the current revenue recognition standard.

Performance Obligations - a performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in the current revenue recognition standard.

A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied.

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Accordingly, at the point in time when quality control requirements are satisfied, revenue net of related discounts is recorded.

License and Royalty Revenue – license revenues are determined based on an assessment of whether the license is distinct from any other performance obligations that may be included in the underlying licensing arrangement.

License and Royalty Revenu e – license revenues are determined based on an assessment of whether the license is distinct from any other performance obligations that may be included in the underlying licensing arrangement.

If the customer is able to benefit from the license without provision of any other performance obligations by the Company and the license is thereby viewed as a distinct or functional license, the Company then determines whether the customer has acquired a right to use the license or a right to access the license.

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Revenue recognition arising from milestone payments is dependent upon the facts and circumstances surrounding the milestone payments.

Milestone payments based on a non-sales metric such as a development-based milestone ( e.g.

, an NDA filing or obtaining regulatory approval) represent variable consideration and are included in the transaction price subject to any constraints.

Milestone payments based on a non-sales metric such as a development-based milestone (i .e ., an NDA filing or obtaining regulatory approval) represent variable consideration and are included in the transaction price subject to any constraints.

If the milestone payments relate to future development, the timing of recognition depends upon historical experience and the significance a third party has on the outcome.

For milestone payments to be received upon the achievement of a sales threshold, the revenue from the milestone payments is recognized at the later of when the actual sales occur or the performance obligation to which the sales relate to has been satisfied.

Co-development and Research Fees – Co-development and research fees are earned through performance of specific tasks, activities or completion of stages of development defined within a contractual development or feasibility study agreement with a customer.

Co-development and Research Fees – co-development and research fees are earned through performance of specific tasks, activities or completion of stages of development defined within a contractual development or feasibility study agreement

with a customer.

The nature of these performance obligations, broadly referred to as milestones or deliverables, are usually dependent on the scope and structure of the project as contracted, as well as the complexity of the product and the specific regulatory approval path necessary for that product.

Accordingly, the duration of the Company’s research and development projects may range from several months to approximately three years .

Accordingly, the duration of the Company’s R&D projects may range from several months to approximately three years .

Although each contractual arrangement is unique, common milestones included in these arrangements include those for the performance of efficacy and other tests, reports of findings, formulation of initial prototypes, production of stability clinical and/or scale-up batches, and stability testing of those batches.

Additional milestones may be established and linked to clinical results of the product submission and/or approval of the product by the FDA and the commercial launch of the product.

Proprietary product sales, net – this net revenue is recognized when product is shipped and title passes to the customer, typically at time of delivery.

Proprietary product revenue, net - this net revenue is recognized when product is shipped and title passes to the customer, typically at time of delivery.

At the time of sale, estimates for various revenue allowances are recorded based on historical trends and judgmental estimates.

For sales of Libervant for patients between two to five years of age, returns allowances and prompt pay discounts are estimated based on contract terms and historical return rates, if available, and these estimates are recorded as a reduction of accounts receivables.

For sales of Libervant for patients between two to five years of age while Libervant had U.S.

market access through April 2025, returns allowances and prompt pay discounts are estimated based on contract terms and historical return rates, if available, and these estimates are recorded as a reduction of receivables.

Once receivables are collected, allowances are reclassified and treated as accrued liabilities.

Similarly determined estimates are recorded relating to wholesaler service fees, co-pay support redemptions, and other rebates, and these estimates are reflected as a component of accrued liabilities.

Once all related variable considerations are resolved and uncertainties as to collectable amounts are eliminated, estimates are adjusted to actual allowance amounts.

Once related variable considerations are resolved and uncertainties as to incurred amounts are eliminated, estimates are adjusted to actual allowance amounts.

Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis.

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Research and Development

Research and development, or R&D, expenses are recorded in accordance with ASC 730, Research and Development and are expensed as incurred.

R&D expenses are recorded in accordance with ASC 730, Research and Development and are expensed as incurred.

R&D expenses include R&D activities, services of external CROs, costs of their clinical research sites, scale-up and validation costs, and other activities.

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• risk-free interest rate

These assumptions require estimates and judgements and changes in those inputs could impact the amount of expenses that are charged to earnings.

For 2025 awards with the vesting based on market conditions, the Company uses a Monte Carlo simulation that considers various variables and assumptions, including:

• simulated 30-day average for the last 30 days of the first pricing period,

• simulated highest 30-day average for any 30-day period throughout the second pricing period,

• discount period based on the vesting term of the awards,

• an estimate of stock price volatility based on the Company's historical volatility,

• expected dividends, if any, and

• risk-free interest rate

These assumptions require estimates and judgments and changes in those inputs could impact the amount of expenses that are charged to earnings.

The Company recognizes compensation expense for the fair value of RSUs and stock option awards over the requisite service period of the awards.

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During the years ended December 31, 2025 and 2024, the fair value of the shares withheld was $ 809 and $ 1,351 , respectively, and was recorded a reduction of Additional paid-in capital in the Statements of Changes in Stockholders’ Deficit and as a financing activity in the Statements of Cash Flows.

The portion of shares yet to be remitted as of 12/31/24 was $ 250 and is disclosed as a non-cash financing activity in the Statements of Cash Flows.

The portion of shares yet to be remitted as of December 31, 2025 and 2024 was $ 0 and $ 250 and is disclosed as a non-cash financing activity in the Statements of Cash Flows.

Per Share Data

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Comprehensive loss includes net loss as well as other changes in stockholders’ deficit that may result from transactions and economic events other than those with stockholders, such as unrealized gains or losses on investments.

For the periods ended December 31, 2024 and 2023, the Company’s comprehensive loss included only its net loss.

For the years ended December 31, 2025 and 2024, the Company’s comprehensive loss included only its net loss.

Fair Value Measurements

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• Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

The Company currently has no Level 2 assets or liabilities.

The Company's Level 2 assets consisted of Treasury bills of $ 40,241 and $ 0 as of December 31, 2025 and 2024, respectively.

• Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, accounts payable, accrued expenses and deferred revenue approximate fair value based on the short-term maturity of these assets and liabilities.

The Company previously granted warrants to certain holders of the Company’s the 12.5 % Notes in connection with its debt repayment and debt refinancing.

The Company also issued pre-funded warrants and warrants in 2022 and warrants in 2023 to purchase shares of Common Stock to certain purchasers in connection with the Securities Purchase Agreements.

The warrants were valued based on the Black-Scholes valuation model performed by an independent third-party appraisal prepared as of the grant date consistent with generally-accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation.

See Note 16, Warrants for further information on these warrants.

The Company's 12.5 % Notes contained a repurchase offer or put option which gave holders of the option the right, but not the obligation, to receive a specified amount of future royalties up to a capped amount.

This put option was valued based on Level 3 inputs and its fair value was based primarily on an independent third-party appraisal consistent with generally-accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants Accounting and Valuation Guide.

See Note 15, Long-Term Debt for further discussion.

In connection with the issuance of the 13.5 % Notes on November 1, 2023, the Company and the Note Holders entered into the Royalty Right Agreements.

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A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the Royalty Right Agreements liability.

During 2024 and 2023, there were no material changes to the significant unobservable

inputs used to recognize the Royalty Right Agreements liability.

Management has updated the projected years of payments to 2034 and the effective interest rate by 0.56 %.

During the year ended December 31, 2025, the Company updated the probability-weighted cash flows for future sales, which decreased the royalty obligation to $ 51,886 and decreased the unamortized discount to $ 25,945 .

The effective interest rate changed by 2.64 %, and the Company updated the projected years of payments to 2035.

During the year ended December 31, 2024, there were no material changes to the probability-weighted cash flows for future sales used to recognize

the Royalty Right Agreements liability.

The Company had used 75% probability of success factor and updated the projected years of payments to 2034 and the effective interest rate by 0.56 %.

See Note 15, Long-Term Debt for further discussion.

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The Company manages its operations as a single segment for purposes of assessing performance and making operating decisions.

For additional information regarding the adoption of ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, see Note 5, Segment Reporting.

See Note 5, Segment Reporting for additional information.

Recent Accounting Pronouncements

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Recently Adopted Accounting Pronouncements:

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures ASU 2023-0 7 , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.

Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.

The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024.

The Company adopted the new disclosure requirements as of and for the years ended December 31, 2024 and December 31, 2023.

Refer to Note 5, Segment Reporting for the required disclosure.

In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) :

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity .

This Accounting Standards Update was issued to address the complexity in accounting for certain financial instruments with characteristics of liabilities and equity.

Among other provisions, the amendments in this ASU significantly change the guidance on the issuer’s accounting for convertible instruments and the guidance on the derivative scope exception for contracts in an entity’s own equity such that fewer conversion features will require separate recognition, and fewer freestanding instruments, like warrants, will require liability treatment.

More specifically, the ASU reduces the number of models that may be used to account for convertible instruments from five to three, amends diluted EPS calculations for convertible instruments, modifies the requirements for a contract that may be settled in an entity’s own shares to be classified in equity and requires expanded disclosures intended to increase transparency.

The Company adopted the new guidance on January 1, 2024.

The adoption of this guidance did not have a material impact on the Company’s financial statements.

In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (Topic 820) :

Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions .

This Accounting Standards Update was issued to clarify the guidance in Topic 820, Fair Value Measurement , when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, and to introduce new disclosure requirements for such equity securities.

The Company adopted the new guidance on January 1, 2024.

The adoption of this guidance did not have a material impact on the Company’s financial statements.

In December 2023, the FASB issued ASU 2023-09— Income Taxes (Topic 740)—Improvements to Income Tax Disclosures.

The ASU modifies the effective tax rate reconciliation table and requires disaggregation of income taxes.

The Company adopted ASU 2023-09 for the year ending December 31, 2025 and added the required disclosures on a prospective basis in Note 22, Income Taxes .

Recent Accounting Pronouncements Not Adopted as of December 31, 2025:

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The Company is currently evaluating the impact from the adoption of ASU 2024-03 on disclosures to its financial statements.

In December 2023, the FASB issued ASU 2023-09— Income Taxes (Topic 740)—Improvements to Income Tax Disclosures.

This Accounting Standards Update was issued to enhance the transparency and decision usefulness of income tax

The ASU requires that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate).

It further requires disclosure on an annual basis of the following information about income taxes paid:

The amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes 2.

The amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received).

Additionally, it requires the following information disclosure:

Income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign 2.

Income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign.

The ASU eliminates certain current disclosure requirements.

These disclosure requirements will be effective for the Company beginning January 1, 2025, with early adoption of the amendments permitted.

The Company is currently evaluating the impact from the adoption of ASU 2023-09 on disclosures to its financial statements.

In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software to provide clarification and improvements to the accounting for internal-use software costs under ASC 350-40, Intangibles – Goodwill and Other – Internal-Use Software.

The guidance includes amendments related to capitalization of implementation costs, subsequent measurement, and related presentation and disclosure requirements.

This ASU will be effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years.

Early adoption is permitted.

The Company is currently evaluating the impact this ASU will have on its financial statements and related disclosures.

Risks and Uncertainties

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The net losses and accumulated deficits were partially offset by gross margins from sales of commercialized licensed and proprietary products, license fees, milestone and royalty payments from commercial licensees and co-development parties.

The Company’s funding requirements have been met by its cash and cash equivalents, as well as its existing equity and debt offerings, including the 13.5 % Senior Secured Notes, as further discussed in Note 15, Long-Term Debt , the ATM facility and other equity offerings, including the underwritten public offering as discussed in Note 1, Company Overview and Equity Transactions.

While the Company’s ability to execute its business objectives and achieve profitability over the longer term cannot be assured, the Company’s on-going business, existing cash and cash equivalents, expense management activities, including, but not limited to the ceasing of R&D activities, as well as access to the equity capital markets through its ATM facility, provide near term liquidity for the Company to fund its operating needs for at least the next twelve months as it continues to execute its business strategy.

The Company’s funding requirements have been met by its cash and cash equivalents, as well as its existing equity and debt offerings, including the 13.5 % Senior Secured Notes, as further discussed in Note 15, Long-Term Debt , the ATM facility and other equity offerings, including the underwritten public offerings as discussed in Note 1 Part B, Company Overview and Equity Transactions.

not limited to the ceasing of R&D activities, as well as access to the equity capital markets through its ATM facility, provide near term liquidity for the Company to fund its operating needs for at least the next twelve months as it continues to execute its business strategy.

Segment Reporting

Operating segments are defined as components of an entity for which separate discrete financial information is available for evaluation by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance.

For the year ended December 31, 2024, the Company has identified one operating and reportable segment.

Operating segments are defined as components of an entity for which separate discrete financial information is available for evaluation by the CODM in deciding how to allocate resources and in assessing performance.

For the years ended December 31, 2025 and 2024, the Company has identified one operating and reportable segment.

The Company defines its operating segment based on internally reported financial information that is regularly reviewed by the CODM to analyze financial performance, make decisions, and allocate resources.

The Company's Chief Executive Officer (“CEO”) is the CODM.

The Company's CEO is the CODM.

The Company manages its operations as a single segment for purposes of assessing performance and making operating decisions.

This segment encompasses the development and advancement of a product pipeline for the treatment of severe allergic reactions, including anaphylaxis, and the Adrenaverse epinephrine prodrug pipeline platform.

Additionally, the Company serves as the exclusive manufacturer for its proprietary product, Libervant, and four licensed commercialized products.

Additionally, the Company serves as the exclusive manufacturer for its proprietary product, Libervant, while it had U.S.

market access, and four licensed commercialized products.

The CODM reviews the segment's profit or loss based on net loss reported on the Statements of Operations and Comprehensive Loss.

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All long-lived assets are held in the United States.

While the Company generated $ 57,561 and $ 50,583 in revenues in 2024 and 2023, respectively, management expects the Company to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials, ultimately seeking regulatory approval.

While the Company generated $ 44,545 and $ 57,561 in revenues for the years ended December 31, 2025, and 2024, respectively, management expects the Company to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials, ultimately seeking regulatory approval and commencing commercialization activities for Anaphylm, if approved by the FDA.

The CODM uses cash forecast models to guide investment decisions and assess entity-wide operating results and performance.

Net loss is used to monitor budget and rolling forecasts versus actual results.

The CODM views specific categories within research and development expenses, selling expenses, and general and administrative expenses as significant due to their direct correlation with cash burn and profitability.

The CODM views specific categories within R&D expenses, selling expenses, and general and administrative expenses as significant due to their direct correlation with cash burn and profitability.

The following table reconciles reported revenues to net loss under the significant expense principle for the years ended December 31, 2025, and 2024:

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Loss from operations ( 71,051 ) ( 30,771 )

Other (expenses) income

( 13,380 ) 7,477

Other income/(expenses), net ( 12,733 ) ( 13,380 )

Net loss before income taxes ( 83,784 ) ( 44,151 )

Income taxes benefits (expense)

Income taxes benefit — 14

Net loss $ ( 83,784 ) $ ( 44,137 )

Comprehensive loss $ ( 83,784 ) $ ( 44,137 )

1 - Personnel costs include payroll expenses, share-based compensation expenses and severance

2 - Other Research and Development expenses include preclinical, consulting, maintenance, and testing fees

1 - R&D Personnel costs include payroll expenses, share-based compensation expenses and severance

2 - Other R&D expenses include preclinical, consulting, maintenance, and testing fees

3 - Selling Personnel costs include payroll expenses, share-based compensation expenses and severance

4 - Other Selling expenses include commercialization and other related expenses

4 - Other General and Administrative expenses include legal/patent fees, insurance fees, IT expenses, investor relations expenses, regulatory fees, facility and other costs

5 - G&A Personnel costs include payroll expenses, share-based compensation expenses and severance

6 - Other General and Administrative expenses include legal/patent fees, legal expenditures, insurance fees, IT expenses, investor relations expenses, regulatory fees, facility and other costs

Revenues and Trade Receivables, Net

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Revenues $ 44,545 $ 57,561

For the year ended December 31, 2025, United States revenues were derived primarily from Indivior (manufacture and supply revenue, and co-development and research fees), and Assertio (manufacture and supply revenue, license and royalty revenue and co-development and research fees).

Ex-United States revenues were derived primarily from Hypera (manufacture and supply revenue, and license and royalty revenue), and Indivior (manufacture and supply revenue, license and royalty revenue and co-development and research fees) for revenue markets outside of the United States.

For the year ended December 31, 2024, United States revenues were derived primarily from Indivior (manufacture and supply revenue, and co-development and research fees), MTPA (license and royalty revenue that was previously recorded as deferred revenue and now recognized due to the termination of the contract), and Assertio (manufacture and supply revenue, license and royalty revenue and co-development and research fees).

Ex-United States revenues were derived primarily from Haisco (license and royalty revenue that was previously recorded as deferred revenue and now recognized due to the termination of the contract), Indivior (manufacture and supply revenue, license and royalty revenue and co-development and research fees), and Hypera (manufacture and supply revenue, license and royalty revenue and co-development and research fees) for revenue markets outside of the United States.

For the year ended December 31, 2023, United States revenues were derived primarily from Indivior (manufacture and supply revenue, and co-development and research fees), Assertio (manufacture and supply revenue, and license and royalty revenue), and Zevra (license and royalty revenue).

Ex-United States revenues were derived primarily from Indivior (manufacture and supply revenue, license and royalty revenue and co-development and research fees) and Hypera (manufacture and supply revenue and license and royalty revenue) for revenue markets outside of the United States.

Trade and other receivable, net consist of the following:

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Contract and other receivables 9,750 2,473

allowance for credit losses

sales-related allowances ( 582 ) ( 48 )

Reclassification into Accrued distribution expenses and sales-related allowances 582 —

Trade and other receivables, net $ 17,763 $ 7,344

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Contract assets consist of products and services provided under specific contracts to customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services, as well as estimated receivables from contracts with third parties.

Other receivables include the current portion related to the Monetization royalty receivable and other receivables.

Sales-related allowances as of December 31, 2024 were estimated in relation to revenues recognized for sales of Libervant for patients between two to five years of age.

Other receivables also include the current portion related to the Monetization royalty receivable and other receivables.

As of December 31, 2025, other receivables also include an insurance reimbursement.

Sales-related allowances as of December 31, 2025 and 2024 were estimated in relation to revenues recognized for sales of Libervant for patients between two to five years of age while Libervant had U.S.

market access.

The following table presents the changes in the allowance for credit losses:

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Sales-Related Allowances

Revenues from sales of products are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay support redemptions.

Revenues from sales of products are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, chargebacks, rebates and co-pay support redemptions.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales.

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The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future.

The adequacy of these provisions is reviewed on a quarterly basis.

The adequacy of these provisions is reviewed on no less than a quarterly basis.

The following table presents the changes in sales-related allowances:

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( 34 ) ( 23 )

Reclassifications $ — $ ( 582 )

Reclassifications into Accrued distribution expenses and sales-related allowances ( 582 ) —

Balance at end of period

Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction of trade receivables, and accruals for wholesaler service fees, co-pay support redemptions and other rebates are reflected as current liabilities.

Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction of trade receivables as of December 31, 2025 and 2024, and accruals for wholesaler service fees, co-pay support redemptions and other rebates are reflected as current liabilities.

The accrued balances relative to these provisions included in Trade and other receivables, net and accrued expenses were $ 0 and $ 906 , respectively, as of December 31, 2025, and $ 48 and $ 665 , respectively, as of December 31, 2024.

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Customers are considered major customers when net revenue exceeds 10% of total revenue for the period or outstanding receivable balances exceed 10% of total receivables.

For the year ended December 31, 2025, Indivor and Hypera represented approximately 73 % and 17 % of total revenue, respectively.

As of December 31, 2025, Indivor and Hypera exceeded the 10% threshold for outstanding receivable balances and represented 69 % and 25 %, respectively, of total trade and other receivables.

For the year ended December 31, 2024, Indivor and Haisco represented approximately 62 % and 12 % of total revenue including the one-time recognition of deferred revenue for Haisco, respectively.

As of December 31, 2024, Indivor and Cosmed exceeded the 10% threshold for outstanding receivable balances and represented 41 % and 16 %, respectively, of total trade and other receivables.

For the year ended December 31, 2023, Indivor represented approximately 80 % of total revenue.

As of December 31, 2023, Indivor and Zevra Therapeutics, Inc.

exceeded the 10% threshold for outstanding receivable balances and represented 65 % and 13 %, respectively of total trade and other receivables .

As of December 31, 2024, Indivor and Hypera exceeded the 10% threshold for outstanding receivable balances and represented 41 % and 16 %, respectively of total trade and other receivables.

Material Agreements

Purchase and Sale agreement with RTW Investments LP

On August 13, 2025, the Company entered into a purchase and sale agreement ("Purchase and Sale Agreement") with funds managed by RTW Investments LP ("RTW" or "Purchaser").

Under the terms of the Purchase and Sale Agreement, in exchange for the Purchaser's payment to the Company of a purchase price of $ 75,000 , upon approval of Anaphylm by the FDA by a specified date, the refinancing of the Company’s existing 13.5 % Notes and certain other customary conditions, the Company agreed to a sale of assigned interests to the Purchaser, including a right for the Purchaser to tiered revenue share payments ranging from 7.5 % to 1.0 % of net sales as defined in the Purchase Agreement (and 9.5 % for the subsequent calendar year period if net sales do not achieve specified level in a calendar year period beginning in 2027) in the United States.

Revenue share payments commence in the first fiscal quarter in which the first commercial sale of Anaphylm in the United States after the closing of the transaction.

Revenue share payments will cease upon the Purchaser's receipt of $ 187,500 by December 31, 2035 or $ 225,000 thereafter.

The Purchase and Sale Agreement contains customary affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness (which restrictions are eliminated after the achievement by the Purchaser of a specified return on its investment), and other provisions customary for transactions of this nature, in each case subject to certain exceptions set forth in the Purchase and Sale Agreement.

As this financing is contingent on events that have not occurred yet and are outside of the Company's control, the accounting consequences for this transaction as of and for the year ended December 31, 2025 have been limited to capitalized legal fees of approximately $ 700 recorded within Other current assets on the Balance Sheets.

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.

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 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 $ 5.0 million 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.

Commercial Exploitation Agreement with Indivior

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The Indivior License Agreement specifies a minimum annual threshold quantity of Suboxone that the Company is obligated to fill and requires Indivior to provide the Company with a forecast of its requirements at various specified times throughout the year.

The Indivior License Agreement provides for payment by Indivior of an agreed upon purchase price per unit until January 1, 2025 and, thereafter, that is subject to annual adjustments based on

changes in an agreed upon price index.

The Indivior License Agreement provides for payment by Indivior of an agreed upon purchase price per unit until January 1, 2025 and, thereafter, that is subject to annual adjustments based on changes in an agreed upon price index.

In addition to the purchase price for the Suboxone supplied, Indivior is required to make certain single digit percentage royalty payments tied to net sales value (as provided for in the Indivior License Agreement) outside of the U.S., subject to annual maximum amounts and limited to the life of the related patents.

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The Indivior Amendment was entered into for the primary purpose of amending the Agreement as follows:

(i) extending the term of the Agreement until August 16, 2026 and thereafter providing for automatic renewal terms of successive one year periods unless Indivior delivers notice to the Company, at least twelve months prior to the expiration of the then current term, of Indivior’s intent not to renew, subject to the earlier termination rights of the parties under the Agreement, and providing that the Agreement will not automatically renew for any renewal term beginning after the expiration of the last to expire of the product patents covered under the Indivior License Agreement;

(i) extending the term of the Agreement until August 16, 2026 and thereafter providing for automatic renewal terms of successive one-year periods unless Indivior delivers notice to the Company, at least twelve months prior to the expiration of the then current term, of Indivior’s intent not to renew, subject to the earlier termination rights of the parties under the Agreement, and providing that the Agreement will not automatically renew for any renewal term beginning after the expiration of the last to

expire of the product patents covered under the Indivior License Agreement;

and (ii) agreeing to transfer pricing and payment terms for supplied product under the Indivior License Agreement.

During the year ended December 31, 2023, in consideration of the agreements between the parties, the Company received a payment of $ 11,482 from Indivior, of which amount $ 5,482 represented:

(a) payment of the portion of a 2022 price increase that had not been previously paid and (b) an estimated payment in 2023 for certain price increases.

During the year ended December 31, 2023, the Company recognized $ 5,482 , of which $ 1,682 was related to the 2022 price increases, in Manufacture and supply revenue and $ 6,000 in Interest income and other income , net on the Statements of Operations and Comprehensive Loss.

There were no retroactive price adjustments included in Manufacture and supply revenue for year ended December 31, 2024.

Supplemental Agreement with Indivior

On September 24, 2017, the Company entered into an agreement with Indivior, or the Indivior Supplemental Agreement.

Pursuant to the Indivior Supplemental Agreement, the Company conveyed to Indivior all existing and future rights in the settlement of various ongoing patent enforcement legal actions and disputes related to the Suboxone product.

The Company also conveyed to Indivior the right to sublicense manufacturing and marketing capabilities to enable an Indivior licensed generic buprenorphine product to be produced and sold by parties unrelated to Indivior or Aquestive.

Under the Indivior Supplemental Agreement, the Company was entitled to receive certain payments from Indivior commencing on the date of the Indivior Supplemental Agreement through January 1, 2023.

Once paid, all payments made under the Indivior Supplemental Agreement are non-refundable.

Through February 20, 2019, the at-risk launch date of the competing generic products of Dr.

Reddy’s Labs and Alvogen, the Company received an aggregate of $ 40,750 from Indivior under the Indivior Supplemental Agreement.

Further payments under the Indivior Supplemental Agreement were suspended until adjudication of related patent infringement litigation was finalized.

No further payments are due to the Company under the Indivior Supplemental Agreement.

See Note 23, Contingencies for details.

All payments made by Indivior to the Company pursuant to the Indivior Supplemental Agreement were in addition to, and not in place of, any amounts owed by Indivior to the Company pursuant to the Indivior License Agreement.

License Agreement with Sunovion Pharmaceuticals, Inc.

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This amount was received as of September 30, 2020 and was included in License and royalty revenues for the twelve months ended December 31, 2020.

Effective March 16, 2020, the Company entered into the First Amendment to the Sunovion License Agreement.

The Amendment was entered into for the primary purpose of amending the Sunovion License Agreement as follows:

minimum annual royalty due from Sunovion to the Company form January 1, 2020 to April 1, 2020, and (iv) modifying the termination provision to reflect the Company’s waiver of the right to terminate the Sunovion License Agreement in the event that KYNMOBI was not commercialized by January 1, 2020.

This Sunovion License Agreement will continue until terminated by Sunovion in accordance with the termination provisions of the Amendment to the Sunovion License Agreement.

Effective March 16, 2020, the Company entered into the First Amendment.

The First Amendment was entered into for the primary purpose of amending the Sunovion License Agreement as follows:

(i) including the United Kingdom and any other country currently in the EU which later withdraws as a member country in the EU for purpose of determining the satisfaction of the condition triggering the obligation to pay the third milestone due under the Sunovion License Agreement, (ii) extending the date after which Sunovion has the right to terminate the Sunovion License Agreement for convenience from December 31, 2024 to March 31, 2028, (iii) modifying the effective inception date of the first minimum annual royalty due from Sunovion to the Company form January 1, 2020 to April 1, 2020, and (iv) modifying the termination provision to reflect the Company’s waiver of the right to terminate the Sunovion License Agreement in the event that KYNMOBI was not commercialized by January 1, 2020.

This Sunovion License Agreement will continue until terminated by Sunovion in accordance with the termination provisions of the First Amendment.

The Sunovion License Agreement continues (on a country-by-country basis) until the expiration of all applicable licensed patents unless earlier terminated under the termination provisions contained therein.

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Under this termination arrangement, the Company has the right to participate in any and all value that Zevra may derive from the commercialization or any other monetization of KP-415 and KP-484 compounds or their derivatives.

Among these monetization transactions are those related to any business combinations involving Zevra and collaborations, royalty arrangements, or other transactions from which Zevra may realize value from these compounds, including the product Azstarys ® .

Among these monetization transactions are those related to any business

combinations involving Zevra and collaborations, royalty arrangements, or other transactions from which Zevra may realize value from these compounds, including the product Azstarys ® .

Licensing and Supply Agreement with Haisco for Exservan™ (Riluzole Oral Film) for ALS Treatment in China

The Company entered into the Haisco Agreement with Haisco, a Chinese limited company listed on the Shenzhen Stock Exchange, effective as of March 3, 2022, pursuant to which Aquestive granted Haisco an exclusive license to develop and commercialize Exservan (riluzole oral film) for the treatment of ALS in China.

The Company entered into the Haisco Agreement with Haisco, effective as of March 3, 2022, pursuant to which Aquestive granted Haisco an exclusive license to develop and commercialize Exservan™ (riluzole oral film) for the treatment of ALS in China.

Under the terms of the Haisco Agreement, Aquestive was the exclusive sole manufacturer and supplier for Exservan in China.

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In June 2024, the Haisco Agreement was terminated, and the Company will not receive any contingent payments under the Haisco Agreement.

The Company recognized previously deferred revenue of $ 7,000 for the upfront payment received in September 2022 on the Company's Statements of Operations and Comprehensive Loss for the year ended December 31, 2024.

The termination agreement released all parties from any existing or ongoing obligations.

Commissions of $ 134 that had been capitalized were expensed immediately in Selling, general, and administrative expenses on the Statements of Operations and Comprehensive Loss.

Compensatory Arrangements of Certain Officers

On May 17, 2022, the Company announced that Keith J.

Kendall, former President and Chief Executive Officer of the Company, was leaving the Company and the Company’s Board of Directors, effective May 17, 2022.

In connection with his departure, Mr.

Kendall and the Company entered into a Separation Agreement, including a Consulting Agreement, dated as of May 17, 2022.

Under the Separation Agreement, in addition to other severance benefits already received by Mr.

Kendall in 2022, Mr.

Kendall received a monthly severance payment for eighteen months following the Termination Date, or November 22, 2023.

By the end of December 31, 2023, all payments due to Mr.

Kendall were made.

Commissions of $ 134 that had been capitalized were expensed immediately in Selling, general, and administrative expenses on the Statements of Operations and Comprehensive Loss for the year ended December 31, 2024.

The Company recognized previously deferred revenue of $ 7,000 for the upfront payment received in September 2022 on the Company's financial statements for the year ended December 31, 2024.

Licensing and Supply Agreement with Atnahs Pharma UK Limited

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As of June 30, 2024 and as part of the termination, the parties were released from any existing or ongoing obligations (except for certain limited non-material post-termination obligations).

Upon termination, previously deferred revenue of $ 3,317 was recognized in the Statements of Operations and Comprehensive Loss for the year ended December 31, 2024 for milestone payments that had been received.

Upon termination, previously deferred revenue of $ 3,317 was recognized for milestone payments that had been received on the Company's financial statements for the year ended December 31, 2024.

Commissions of $ 57 that had been capitalized were expensed immediately in Selling, general, and administrative expenses on the Statements of Operations and Comprehensive Loss for the year ended December 31, 2024.

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The carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, accounts payable and accrued expenses, and deferred revenue approximate their fair values based on the short-term maturity of these assets and liabilities.

The Company granted warrants to certain noteholders in connection with its debt repayment and debt refinancing during 2020 and 2019, respectively.

The Company granted warrants to certain noteholders in connection with its debt repayment and debt refinancing of the 12.5 % Notes during 2020 and 2019, respectively.

Those warrants were valued based on Level 3 inputs and their fair value was based primarily on an independent third-party appraisal prepared as of the grant date consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation.

The warrants expired on June 30, 2025.

See Note 16 , Warrants for further information on these warrants.

The Company’s 12.5 % Senior Secured Notes contained a repurchase offer or put option which gives holders of the option the right, but not the obligation, to require the Company to redeem the 12.5 % Notes up to a capped portion of milestone payments resulting from the Monetization Agreement.

This put option was valued based on Level 3 inputs and its fair value was based primarily on an independent third-party appraisal consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants Accounting and Valuation Guide.

See Note 15, Long-Term Debt for further discussion.

In June 2022, the Company issued pre-funded warrants to purchase up to 4,000,000 shares of Common Stock and Common Stock Warrants to purchase up to 8,850,000 shares of Common Stock in connection with its Securities Purchase Agreements with certain purchasers.

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a tiered royalty between 1.0 % to 2.0 % of annual worldwide net sales of Libervant (diazepam) Buccal Film until the earlier of (1) the first sale of Anaphylm and (2) eight years from the first sale of Libervant.

Those Royalty Agreements were valued based on Level 3 inputs and their fair value was based primarily on internal management estimates developed based on third-party data and reflect management’s judgements, current market conditions, and forecasts.

The initial fair value measurement of the Royalty Right Agreements was determined based on significant unobservable inputs, including the discount rate, estimated probabilities of success, and the estimated amount of future sales of Anaphylm and Libervant.

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Total depreciation and amortization related to property and equipment was $ 548 and $ 640 for the years ended December 31, 2025 and 2024, respectively.

No impairment losses were recognized for the year ended December 31, 2024.

For the year ended December 31, 2023, the Company recognized a $ 216 impairment of an asset held in Construction in progress account that was assessed by management as no longer usable.

Such impairment charge is included in the Manufacture and supply expenses on the Statements of Operations and Comprehensive Loss.

No impairment losses were recognized for the years ended December 31, 2025 and 2024.

Right-of-Use Assets and Lease Obligations

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These leases, as amended, provide remaining terms between 2.2 years and 7.8 years, including renewal options expected to be exercised to extend the lease periods.

See Part II, Properties for details.

During the year ended December 31, 2023, the Company recognized a lease supporting its manufacturing facilities as a finance lease.

Commitments under finance leases are not significant, and are included in Property and equipment, net, and Notes Payable, net on the Balance Sheets.

See Part II, Properties for details.

The Company does not recognize a right-to-use asset and lease liability for short-term leases, which have terms of 12 months or less on its Balance Sheets.

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Measurement of the operating lease liability reflects a range of an estimated discount rate of 14.8 % to 15.6 % applied to minimum lease payments, including expected renewals, based on the incremental borrowing rate experienced in the Company’s collateralized debt refinancing.

The Company’s lease costs are recorded in manufacture and supply, research and development and selling, general and administrative expenses in its Statements of Operations and Comprehensive Loss.

For the years ended December 31, 2024 and

2023, total operating lease expenses totaled $ 1,814 and $ 1,745 , respectively, including variable lease expenses such as common area maintenance and operating costs of $ 487 and $ 447 , respectively.

The Company’s lease costs are recorded in manufacture and supply, R&D and selling, general and administrative expenses in its Statements of Operations and Comprehensive Loss.

For the years ended December 31, 2025 and 2024, total operating lease expenses totaled $ 1,783 and $ 1,814 , respectively, including variable lease expenses such as common area maintenance and operating costs of $ 449 and $ 487 , respectively.

The Company’s payments due under its operating leases are as follows:

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Intangible assets, net $ — $ —

Amortization expense was $ 78 and $ 157 for each of the years ended December 31, 2024 and 2023, respectively.

There was no amortization expense incurred during the year ended December 31, 2025.

Amortization expense was $ 78 for the year ended December 31, 2024.

In June 2024, in connection with a termination of an agreement, the Company recorded a gain on termination of the contract in the amount of $ 1,500 , which was partially offset by an adjustment to the remaining balance of $ 1,200 of the intangible asset .

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In connection with the Monetization Agreement, the Company performed an assessment under ASC 860, Transfer and Servicing to determine whether the existing receivable was transferred to Marathon and concluded it was not transferred.

As of December 31, 2024 and 2023, Royalty receivable consists of four and five , respectively, annual minimum payments due from Sunovion, the last of which is due in March, 2028.

As of December 31, 2025 and 2024, Royalty receivable consists of three and four , respectively, annual minimum payments due from Sunovion, the last of which is due in March, 2028.

The current portion of the royalty receivable is included in Trade and other receivables, net.

See Note 17, Sale of Future Revenue for further details on how this receivable relates to the Monetization Agreement transaction.

Non-current portion of commissions capitalized under ASC 340, Other Assets and Deferred Costs, is recorded within Other non-current assets on the Balance Sheets.

Commissions of $ 191 were expensed in Selling, general, and administrative expenses on the Statements of Operations and Comprehensive Loss for the year ended December 31, 2024 due to the termination of the underlying contracts.

The non-current portion of costs to obtain contracts capitalized under ASC 340, Other Assets and Deferred Costs, is recorded within Other non-current assets on the Balance Sheets as of December 31, 2025 and 2024.

Accrued Expenses

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Interest payable

Other 128 300

Total accrued expenses $ 5,029 $ 5,907

The increase in Accrued compensation is mostly related to an increase in the current portion of accrued severance as of December 31, 2024.

The decrease in Interest payable is due to the timing of interest payments on the 13.5 % Senior Notes.

The fourth quarter 2024 interest payment on the 13.5 % Senior Notes was made on December 30, 2024.

As of December 31, 2023, interest payable on the 13.5 % Senior Notes was due on January 2, 2024.

See Note 15, Long-Term Debt, for discussion of 13.5 % Notes and related interest payable.

Accrued distribution expenses and sales returns provision mostly represent estimated liabilities for wholesaler service fees, co-pay support redemptions and other rebates related to the proprietary product Libervant and returns related to the period prior to the outlicensing of our proprietary product, Sympazan.

The decrease in Accrued compensation is mostly related to a decrease in the current portion of accrued severance as of December 31, 2025 and timing of payroll-related payments.

The increase in Accrued distribution expenses and sales return provision reflects a reclassification from Trade receivables and other receivables, net.

Refer to Note 6, Revenues and Trade Receivables, Net.

Accrued distribution expenses and sales returns provision mostly represent estimated liabilities for returns, wholesaler service fees, co-pay support redemptions and other rebates related to the proprietary product Libervant and returns and other expenses related to the proprietary product Sympazan (prior to outlicensing to Assertio in October 2022).

Long-Term Debt

13.5 % Senior Secured Notes

On July 15, 2019, the Company completed the private placement of up to $ 100,000 aggregate principal of its 12.5 % Notes due 2025 and issued Warrants to purchase 2,000,000 shares of Common Stock, at $ 0.001 par value per share.

Upon closing of the Base Indenture, the Company issued $ 70,000 of the 12.5 % (the "Initial Notes") along with the Warrants and rights of first offer (the “First Offer Rights”) to the noteholders participating in this transaction.

Issuance of the Initial Notes and Warrants provided net proceeds of $ 66,082 .

On November 3, 2020, the Company entered into the First Supplemental Indenture (the "First Supplemental Indenture" and, together with all other subsequent supplemental indentures and the Base Indenture, collectively, the "Indenture") by and among the Company and U.S.

Bank National Association, as Trustee (the "Trustee") and Collateral Agent thereunder to the Base Indenture, by and between the Company and the Trustee.

Under the Second Supplemental Indenture, dated November 20, 2020, the Company repaid $ 22,500 of its $ 70,000 outstanding 12.5 % Notes from the upfront proceeds received under the Monetization Agreement.

Further, the Company entered into an additional Purchase Agreement with its noteholders whereby the Company issued in aggregate $ 4,000 of additional 12.5 % Notes (the "Additional Notes") in lieu of paying a prepayment premium to two noteholders on the early repayment of the 12.5 % Notes discussed above.

The result of these two transactions reduced the net balance of the Company's 12.5 % Senior Notes outstanding in the aggregate to $ 51,500 at December 31, 2020.

The $ 4,000 principal issuance would be repaid proportionally over the same maturities as the other 12.5 % Notes.

The Company also paid to one of its noteholders a $ 2,250 premium as result of the early retirement of debt.

The Company accounted for the $ 22,500 debt repayment as a debt modification of the 12.5 % Notes.

The fees paid to the noteholders inclusive of (i) $ 2,250 early premium prepayment and (ii) $ 4,000 issuance of Additional Notes in lieu of paying a prepayment penalty were recorded as additional debt discount, amortized over the remaining life of the 12.5 % Notes using the effective interest method.

Loan origination costs of $ 220 associated with the Additional Notes were expensed as incurred.

Existing deferred discounts and loan origination fees on the 12.5 % Notes are amortized as an adjustment of interest expense over the remaining term of modified debt using the effective interest method.

The First Supplemental Indenture contained a provision whereby, as the Company receives any cash proceeds from the Monetization Agreement, each noteholder has the right to require the Company to redeem all or any part of such noteholder’s outstanding 12.5 % Notes at a repurchase price in cash equal to 112.5 % of the principal amount, plus accrued and unpaid interest.

This repurchase offer was capped at 30 % of the cash proceeds received by the Company as the contingent milestones were attained, if any, up through June 30, 2025.

A valuation study was performed by an independent third-party appraiser and updated in June 30, 2023.

Based on the valuation study, the put option was valued at $ 0 .

The resulting $ 45 decrease in the put option fair value was recorded in interest income and other income, net on the Statements of Operations and Comprehensive Loss for the year ended December 31, 2023.

The embedded put option was deemed to be a derivative under ASC 815 Derivatives and Hedging , which required the recording of the embedded put option at fair value subject to remeasurement at

each reporting period.

In addition, as of the closing of this transaction, the Company issued to the holders of the 12.5 % Notes warrants to purchase 143,000 shares of the Company's Common Stock.

As of December 31, 2023, the put option was no longer in place due to the refinancing of the 12.5 % Notes.

On October 7, 2021, the Company entered into the Fourth Supplemental Indenture, pursuant to which the amortization schedule for the 12.5 % Notes was amended to provide for the date of the first principal payment to be extended from September 30, 2021 to March 30, 2023.

The Fourth Supplemental Indenture did not change the maturity date of the 12.5 % Notes or the interest payment obligation due under the 12.5 % Notes.

In connection with the Fourth Supplemental Indenture, the Company entered into a Consent Fee Letter with the holders of the 12.5 % Notes (the “Consent Fee Letter”), pursuant to which the Company agreed to pay the holders of the 12.5 % Notes an additional cash payment ("Consent Fee") of $ 2,700 in the aggregate, payable in four quarterly payments beginning May 15, 2022.

The last Consent Fee installment of $ 675 was made in February 2023.

The 12.5 % Notes provided a stated fixed interest rate of 12.5 %, payable quarterly in arrears, with the final quarterly principal repayment of 12.5 % Notes due at maturity on June 30, 2025.

The Company could have elected, at its option, to redeem the 12.5 % Notes at any time at premiums that range from 101.56 % of outstanding principal if prepayment occurs on or after the fifth anniversary of the issue date of the Initial Notes to 112.50 % if payment occurs during the third year after the issuance of the 12.5 % Notes.

The Indenture also included change of control provisions under which the Company may have been required to redeem the 12.5 % Notes at 101 % of the remaining principal plus accrued interest at the election of the noteholders.

During the year ended December 31, 2023, the Company redeemed $ 5,647 of its outstanding 12.5 % Notes.

The Company also paid a $ 353 prepayment premium as a result of the early retirement of debt which was reflected as a loss on extinguishment of debt on the Company's Statements of Operations and Comprehensive Loss for the year ended December 31, 2023.

The Company also made three scheduled principal payments totaling $ 11,463 during the year ended December 31, 2023.

Amortization expense arising from deferred debt issuance costs and debt discounts related to the 12.5 % Notes for the year ended December 31, 2023 was $ 13 .

On November 1, 2023, the Company issued the 13.5 % Notes, as described below, and used the proceeds from the issuance to repay the outstanding principal balance under the 12.5 % Notes of $ 36,014 , including accrued and unpaid interest and a redemption fee.

The Company accounted for this transaction as an extinguishment of debt and recognized a debt extinguishment charge of $ 1,029 for the year ended December 31, 2023.

The debt extinguishment charge is included in Loss on the extinguishment of debt in the Company’s Statements of Operations and Comprehensive Loss.

13.5 % Senior Secured Notes

On November 1, 2023, the Company entered into an Indenture Agreement with certain institutional investors (the “Note Holders”) and issued $ 45,000 aggregate principal amount of its 13.5 % Notes due 2028.

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The 13.5 % Notes are senior secured obligations of the Company and mature on November 1, 2028.

The 13.5 % Notes bear interest at a fixed rate of 13.5 % per year, payable quarterly commencing on December 30, 2023 with the first interest payment due on January 2, 2024.

The 13.5 % Notes bear interest at a fixed rate of 13.5 % per year, payable quarterly commencing on December 30, 2023.

On each payment date commencing on June 30, 2026, the Company will pay an installment of principal of the 13.5 % Notes pursuant to a fixed amortization schedule, along with the applicable Exit Fee.

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If the Company undergoes a change of control, the Note Holders may require the Company to repurchase for cash all or any portion of the 13.5 % Notes at a change of control repurchase price equal at 108.5 % plus the Exit Fee of the remaining principal, plus accrued interest at the election of the Note Holders.

The Indenture permits the Company, upon the continuing satisfaction of certain conditions, including that the Company has at least $ 100,000 of net revenues for the most recently completed twelve calendar month period, to enter into an ABL facility not to exceed $ 10,000 .

The Indenture Agreement permits the Company, upon the continuing satisfaction of certain conditions, including that the Company has at least $ 100,000 of net revenues for the most recently completed twelve calendar month period, to enter into an ABL facility not to exceed $ 10,000 .

The ABL Facility may be collateralized only by assets of the Company constituting inventory, accounts receivable, and the proceeds thereof.

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These inputs are derived using internal management estimates developed based on third-party data and reflect management’s judgements, current market conditions, and forecasts.

These inputs are derived using internal management estimates developed based on third-party data and reflect management’s judgments, current market conditions, and forecasts.

The Royalty Right Agreements fair value is estimated by applying probability-weighted cash flows for future sales, which are then discounted to present value.

1 unchanged sentence

A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the Royalty Right Agreements liability.

The following table summarizes the significant unobservable inputs used in the initial fair value measurement of the Royalty Right Agreements as of December 31, 2023:

The following table summarizes the significant unobservable inputs used in the fair value measurement of the Royalty Right Agreements:

Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable)

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Projected Years of Payments 2025 - 2035

As of December 31, 2024, there were no material changes to the significant unobservable inputs used to recognize the Royalty Right Agreements liability.

Management has updated the projected years of payments to 2034 and the effective interest rate by 0.56 %.

The effective interest rate changed by 2.64 %, and the Company updated the projected years of payments to 2035.

During the year ended December 31, 2024, there were no material changes to the probability-weighted cash flows for future sales used to recognize the Royalty Right Agreements liability.

The Company had used 75% probability of success factor and updated the projected years of payments to 2034 and the effective interest rate by 0.56 %.

Since the Royalty Right Agreements were issued in connection with the 13.5 % Notes, the Company allocated the proceeds to the two instruments based on their relative fair values.

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The Company determined the allocated fair value by calculating the present value of estimated future royalties to be paid to Note Holders over the life of the arrangement.

The excess of future estimated royalty payments of $ 56,926 over the $ 13,856 of allocated fair value is recognized as a discount related to the Royalty Right Agreements and is amortized as interest expense using the effective interest method.

The excess of future estimated royalty payments over the allocated fair value is recognized as a discount related to the Royalty Right Agreements and is amortized as interest expense using the effective interest method.

The allocated amounts of $ 13,856 when combined with the Exit Fee of $ 2,000 , original issue discount of $ 1,125 and debt issuance costs of $ 3,517 , resulted in debt discount of $ 20,498 .

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( 7,630 ) ( 12,646 )

Notes payable, current ( 9,964 ) —

Notes payable, long-term

9 unchanged sentences

$ 25,941 $ 20,129

Scheduled principal payments on the 13.5 % Notes as of December 31, 2024 are as follows:

Scheduled principal payments net of exit fee on the 13.5 % Notes as of December 31, 2025 are as follows:

Total $ 45,000

Warrants Issued to 12.5 % Senior Secured Noteholders

Warrants that were issued in conjunction with the Initial Notes (the “Initial Warrants”) and Additional Notes (the “Additional Warrants”) expire on June 30, 2025 and entitle the noteholders to purchase up to 2,143,000 shares of Common Stock and included specified registration rights.

Warrants that were issued in conjunction with the Initial Notes (the “Initial Warrants”) and Additional Notes (the “Additional Warrants”) entitled the noteholders to purchase up to 2,143,000 shares of Common Stock and included specified registration rights.

Management estimated the fair value of the Initial Warrants to be $ 6,800 and the Additional Warrants to be $ 735 , each based on an assessment by an independent third-party appraiser.

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Additionally, since the Initial Warrants and Additional Warrants issued do not provide warrant redemption or put rights within the control of the holders that could require the Company to make a payment of cash or other assets to satisfy the obligations under the warrants, except in the case of a “cash change in control”, the fair value attributed to the warrants is presented in Additional Paid-in Capital in the Company’s Balance Sheets.

There were no warrants exercised as it relates to the Initial Warrants and the Additional Warrants during the years ended December 31, 2025.

During the year ended December 31, 2024, 30,645 of the Additional Warrants were exercised with the Company receiving proceeds of $ 165 .

There were no warrants exercised during the year ended December 31, 2023.

Warrants to purchase a total of 1,683,784 shares of Common Stock with exercise prices of $ 4.25 and $ 5.38 for 1,571,429 warrants and 112,355 warrants, respectively, remained outstanding as of December 31, 2024.

Warrants to purchase a total of 1,714,429 shares of Common Stock with exercise prices of $ 4.25 and $ 5.38 for 1,571,429 warrants and 143,000 warrants, respectively, remained outstanding as of December 31, 2023 See Note 15, Long-Term Debt.

See Note 15, Long-Term Debt.

The Initial Warrants and Additional Warrants expired on June 30, 2025.

Warrants Issued Under Securities Purchase Agreements

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The pre-funded warrants entitled purchasers to purchase up to 4,000,000 shares of Common Stock and were exercised in full during the year ended as of December 31, 2022.

The Common Stock Warrants expire on June 8, 2027 and entitle the purchasers to purchase up to 8,850,000 shares of Common Stock at a price ranging from $ 0.96 to $ 1.09 per share.

The Common Stock Warrants expire on June 8, 2027 and entitle the purchasers to purchase up to 8,850,000 shares of Common Stock at an exercise price of $ 0.96 per share.

Management estimated the fair value of the pre-funded warrants and Common Stock warrants to be $ 5,874 based on an assessment by an independent third-party appraiser.

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The fair value of the New warrants is treated as equity and is presented in Additional Paid-in Capital in the Company’s Balance Sheets.

On August 2, 2023, 5,000,000 of the Existing Warrants were exercised pursuant to the Securities Purchase Agreement with the Exercising Holder, with the Company receiving gross proceeds therefrom of $ 4,800 .

In total, 8,689,452 Common Stock warrants issued pursuant to the Securities Purchase Agreements with proceeds of approximately $ 8,307 were exercised during the year ended December 31, 2023.

The Company incurred $ 35 in relation to this transaction.

During the year ended December 31, 2025, 550,000 shares were issued upon the exercise of warrants, with the Company receiving proceeds of $ 1,430 as it relates to the Warrants issued under Securities Purchase Agreements.

There were no warrants issued or exercised as it relates to the Warrants issued under Securities Purchase Agreements during the year ended December 31, 2024.

As of December 31, 2024, in addition to the warrants to purchase 2,750,000 shares of Common Stock described above, there remained outstanding warrants to purchase 160,548 shares of Common Stock at an exercise price of $ 0.96 and warrants to purchase 1,683,784 shares of Common Stock outstanding related to the original issuance of the 12.5 % Notes prior to the debt refinancing described above in this Note 15, Long-Term Debt , with exercise prices of $ 4.25 and $ 5.38 for 1,571,429 warrants and 112,355 warrants, respectively.

As of December 31, 2025, in addition to the remaining warrants to purchase 2,200,000 shares of Common Stock with an exercise price of $ 2.60 per share described above, there remained outstanding warrants to purchase 160,548 shares of Common Stock at an exercise price of $ 0.96 .

Sale of Future Revenue

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The sum of future royalty payments less the $ 50,000 in proceeds received and future contingent payments will be recorded as interest expense over the life of the Monetization Agreement.

At execution, the

estimate of this total interest expense resulted in an effective annual interest rate of approximately 24.9 %.

At execution, the estimate of this total interest expense resulted in an effective annual interest rate of approximately 24.9 %.

This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the life of the Monetization Agreement.

The Company assesses the estimated royalty and milestone payments to Marathon from Sunovion and contingent milestone payments from Marathon to the Company.

To the extent the amount or timing of such payments is materially different from the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense.

To the extent the amount or timing of such payments is materially different from the original estimates, an adjustment will be recorded prospectively to

increase or decrease interest expense.

There are a number of factors that could materially affect the amount and timing of royalty and milestone payments to Marathon from Sunovion and, correspondingly, the amount of interest expense recorded by the Company, most of which are not under the Company’s control.

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Other Non-Current Liabilities

The Company’s other non-current liabilities at December 31, 2025 consisted of a confidential legal settlement net liability and AROs of $ 2,065 .

The Company’s other non-current liabilities at December 31, 2024 consisted of AROs of $ 2,039 and severance liabilities of $ 356 .

The Company’s other non-current liabilities at December 31, 2023 consisted of AROs of $ 2,016 .

AROs consists of estimated future spending related to removing certain leasehold improvements at the Company’s facilities in Portage, Indiana and Warren, New Jersey, and returning all facilities to their original condition.

Depreciation expense related to the ARO assets included in overall depreciation expense for the periods ended December 31, 2024 and 2023 were $ 11 and $ 7 , respectively.

Below is a schedule of activity in the Company’s liability for AROs for the year ended December 31, 2024 and 2023.

Depreciation expense related to the ARO assets included in overall depreciation expense were $ 11 for the years ended December 31, 2025 and 2024.

Below is a schedule of activity in the Company’s liability for AROs for the years ended December 31, 2025 and 2024.

Balance at December 31, 2023 $ 2,016

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Therefore, basic and diluted net loss per share are the same for the years ended December 31, 2025 and 2024 as reflected below.

Year Ended December 31, 2024 Year Ended December 31, 2023

Year Ended December 31,

Net loss $ ( 83,784 ) $ ( 44,137 )

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The service-based restricted stock units and stock options that have been awarded are subject to graded vesting over a service period, which is typically three years .

The restricted stock units with vesting based on market conditions were awarded in 2023 and vest in three years on the anniversary of the first tranche award.

The restricted stock units with vesting based on market conditions were awarded in 2023 and 2025 and vest in three years on the anniversary of the first tranche award.

Compensation cost is recognized for restricted stock units, both service-based awards and market conditions vesting-based awards, on a straight line basis over the requisite service period for each award granted.

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The Company recognized share-based compensation in its Statements of Operations and Comprehensive Loss during the periods presented as follows:

Year Ended December 31,

Expense classification:

Year Ended December 31, 2024 Year Ended December 31, 2023

Manufacture and supply $ 481 $ 374

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Total share-based compensation expenses $ 7,624 $ 7,099

The following tables provide information about the Company’s restricted stock unit and stock option activity during the year ended December 31, 2024 and 2023.

The following tables provide information about the Company’s restricted stock unit and stock option activity during the years ended December 31, 2025 and 2024.

Restricted Stock Units

The following tables summarize the Company’s awards of service-based and market conditions vesting-based restricted stock units for the years 2024 and 2023:

The following tables summarize the Company’s awards of service-based and market conditions vesting-based restricted stock units during the years ended December 31, 2025 and 2024:

Restricted Stock Unit Awards (RSUs) - Service-based:

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Expected to vest as of December 31, 2025 2,548 $ 3.22

The Company granted 1,470,300 service-based restricted stock units during 2024.

The Company granted 1,874,300 service-based restricted stock units during 2023.

The Company granted 1,602,050 service-based restricted stock units during the year ended December 31, 2025.

The Company granted 1,470,300 service-based restricted stock units during the year ended December 31, 2024.

During 2025, the total grant date fair market value of shares vested was $ 3,236 .

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The service-based restricted stock units granted to employees are subject to a three-year graduated vesting schedule and are not subject to performance-based criteria other than continued employment.

2022 Inducement Equity Incentive Plan

In accordance with NASDAQ Listing Rule 5635(c)(4), the Company adopted the 2022 Equity Inducement Plan approved by the Compensation Committee of the Board of Directors of the Company effective as of July 29, 2022.

There were no awards outstanding under this Plan as of December 31, 2024.

Restricted Stock Unit Awards (RSUs) - Market conditions vesting-based:

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Unvested as of December 31, 2023 1,332 $ 2.40

Granted 1,332 2.40

Forfeited — —

Vested ( 250 ) 2.41

Unvested as of December 31, 2024 1,082 $ 2.40

Granted 784 2.82

Forfeited ( 138 ) 2.82

Vested ( 250 ) 2.41

Unvested as of December 31, 2025 1,728 $ 2.55

Expected to vest as of December 31, 2025 1,641 $ 2.54

There were no market conditions vesting-based restricted stock units granted in 2024.

The Company granted 1,332,000 market conditions vesting-based restricted stock units during 2023.

The Company granted 784,350 market conditions vesting-based restricted stock units during the year ended December 31, 2025.

There were no market conditions vesting-based restricted stock units granted during the year ended December 31, 2024.

As of December 31, 2025, $ 1,450 of total unrecognized compensation expenses related to unvested market conditions vesting-based restricted stock units are expected to be recognized over a remaining weighted average period of 1.03 years.

The market conditions vesting-based restricted stock units vest based on a Performance Price measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three-year performance period (which ends on the third anniversary of the grant date).

The 2023 market conditions vesting-based restricted stock units vest based on a Performance Price measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three-year performance period (which ends on the third anniversary of the grant

To the extent the Performance Price is less than $ 1.75 , the Vesting Percentage will be zero .

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In no event will the Vesting Percentage exceed 150 %.

The Company’s estimates of the fair value of market conditions vesting-based awards at their grant or valuation dates were based on a Monte Carlo simulation and considered various variables and assumptions, including a simulated 30 -day average at the end of the Performance period including the following assumptions:

The 2025 market conditions vesting-based restricted stock units were measured over a three-year performance period.

The performance period is split into two pricing periods.

The first pricing period commences on the grant date and ends on the calendar day immediately proceeding the second anniversary of the grant date.

The second pricing period commences on the second anniversary of the grant date and ends on the third anniversary of the grant date, The performance price for the first pricing period is calculated based on the 30-day average price observed for the last 30 days of the first pricing period.

The performance price for the second pricing period is calculated based on the highest 30-day average for any 30-day period throughout the second pricing period.

To the extent the Performance Price is less than $ 6.00 , the Vesting Percentage will be zero .

To the extent the Performance Price is $ 6.00 , the Vesting Percentage will be 50 %.

To the extent the Performance Price is $ 6.01 or greater, but less than $ 7.00 , the Vesting Percentage will be a prorated amount between 50.01 % and 99.99 %, based on straight-line interpolation.

To the extent the Performance Price is $ 7.00 , the Vesting Percentage will be 100 %.

To the extent the Performance Price is $ 7.01 or greater, but less than $ 8.00 , the Vesting Percentage will be a prorated amount between 100.01 % and 149.99 %, based on straight-line interpolation.

To the extent the Performance Price is $ 8.00 or greater, the Vesting Percentage will be 150 %.

In no event will the Vesting Percentage exceed 150 %.

The Company’s estimates of the fair value of the 2025 market conditions vesting-based awards at their grant or valuation dates were based on a Monte Carlo simulation and considered various variables and the following assumptions:

Year Ended December 31, 2025

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Expected volatility 91.5 %

Expected term (years) 2.74 - 3.00

Risk-free interest rate 3.9 %

Stock price at grant date

$ 2.01 - $ 2.04

Stock option awards

The following table summarizes the Company’s stock option activity for the years during 2024 and 2023:

The following table summarizes the Company’s stock option activity during the years ended December 31, 2025 and 2024:

(in 000s, except share price data) Number

4 unchanged sentences

Outstanding as of December 31, 2023 5,733 $ 5.58 6.41 $ 1,082

6,028 $ 5.48 7.50 $ 38

Granted 1,024 4.83

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Outstanding as of December 31, 2024 6,301 5.68 6.08 4,009

5,733 $ 5.58 6.41 $ 1,082

Granted 1,040 2.98

( 357 ) $ 2.05

Forfeited and Expired ( 215 ) 4.60

Outstanding as of December 31, 2025 6,558 5.59 5.58 14,918

6,301 $ 5.68 6.08 $ 4,009

Expected to vest as of December 31, 2025 6,482 5.61 5.54 14,705

6,234 $ 5.69 6.05 $ 3,980

Exercisable as of December 31, 2025 5,136 $ 6.07 4.65 $ 11,185

4,861 $ 6.24 5.33 $ 2,898

The weighted average grant date fair value of stock options granted during 2024 and 2023 was $ 3.98 and $ 1.50 , respectively.

The weighted average grant date fair value of stock options granted during the years ended December 31, 2025 and 2024 was $ 2.38 and $ 3.98 , respectively.

During the year ended December 31, 2025, 1,040,000 stock options were granted with an exercise price of $ 2.98 and accordingly, given the Company’s share price of $ 6.46 at December 31, 2025, the aggregate

intrinsic value provided by certain shares granted during this period was approximately $ 3,600 .

During the year ended December 31, 2024, 1,023,900 stock options were granted with an exercise price of $ 4.83 and accordingly, given the Company’s share price of $ 3.56 at December 31, 2024, the intrinsic value provided by certain shares granted during this period was de minimis.

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These stock options are not subject to performance-based criteria other than continued employment.

2022 Inducement Equity Incentive Plan

There were 50,000 service-based awards and 50,000 options granted and outstanding under this Plan as of December 31, 2025.

The options and service-based awards granted under this Plan are included in the tables above.

As of December 31, 2025, 900,000 shares remained available for grant under this Plan.

Employee Stock Purchase Plan

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Under the ESPP, employees of the Company may elect to purchase the Company’s Common Stock at the lower of 85 % of the fair value of shares on either the first or last day of the offering period.

Under the ESPP, a total of 250,000 shares of Common Stock were initially reserved for issuance.

During the year ended 2024 and 2023, 35,374 and 36,168 shares were purchased and issued through the ESPP at total discounts of $ 42 and $ 27 , respectively.

During the years ended December 31, 2025 and 2024, 38,377 and 35,374 shares were purchased and issued through the ESPP at total discounts of $ 81 and $ 42 , respectively.

As of December 31, 2025, 307,845 shares remained available for issuance under the ESPP.

Employee Benefit Plans

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Total contributions made to the plan by the Company for the years ended December 31, 2025 and 2024 were $ 920 and $ 849 , respectively.

The Company adopted ASU 2023-09 for the year ending December 31, 2025 and added the required disclosures on a prospective basis.

The components of the provision for income taxes are as follows:

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Year Ended December 31,

$ ( 14 ) $ 245

Provision for Income Tax

$ ( 14 ) $ 245

The tax effect of temporary differences between the tax bases of assets and liabilities and their financial reporting amounts that give rise to the deferred tax assets and deferred tax liabilities as of December 31, 2025 and 2024 are as follows:

Deferred tax assets:

Accounts receivable $ — $ 4

Inventory $ 435 $ 337

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NOL carryforwards 48,764 34,689

Interest limitation imposed by the TJCA 11,594 9,880

Interest limitation imposed by the TCJA 11,392 11,594

Stock Compensation 2,966 6,862

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OID and Deferred Financing Cost

Other 4,724 143

114,921 95,348

Deferred tax liabilities:

OID and Deferred Financing Cost

Right of use assets ( 1,161 ) —

Prepaid expenses ( 586 ) ( 795 )

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Net deferred tax asset/(liability) $ — $ —

At December 31, 2024 and 2023, the Company had federal net operating loss carryforwards of $ 128,658 and $ 101,029 , respectively, a significant portion of which carryforward for an indefinite period.

At December 31, 2025 and 2024, the Company had federal net operating loss carryforwards of $ 184,246 and $ 128,658 , respectively, which can be carried forward for an indefinite period.

At December 31, 2025 and 2024, the Company also had state net operating loss carryforwards of $ 212,690 and $ 139,189 , respectively, which begin expiring in 2035.

As a result of the December 2017 U.S.

Tax Cuts and Jobs Act (“TCJA”), updated regulations under section 163(j) create new limitations on deductible interest expense.

For the year ended December 31, 2024, the Company’s interest expense deduction under 163(j) will be limited for tax purposes based on a calculation of 30% of its EBIT on a tax basis.

The Company has determined, based upon available evidence, that is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax assets.

December 31, 2025 the Company had $ 7,214 of federal R&D credits and $ 398 of state R&D credits, which begin expiring in 2037 and 2031, respectively.

The Company has determined, based upon available evidence, that it is more likely than not that the net deferred tax asset will not be realized and accordingly, has provided a full valuation allowance against its net deferred tax assets.

Valuation allowances of $ 113,174 , and $ 94,553 have been established at December 31, 2025 and 2024, respectively.

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As a result, the use of NOL carry forwards from the current and prior periods are subject to annual limitations.

The TCJA requires taxpayers to capitalize and amortize R&D expenditures under section 174 for tax years beginning after December 31, 2021.

For the years ended December 31, 2024 and 2023, the capitalized R&D costs were $ 17.3 million and $ 12.6 million, respectively.

The Company will amortize these costs for tax purposes over five years if the R&D was performed in the U.S.

and over 15 years if the R&D was performed outside the U.S.

Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns.

On July 4, 2025, the President signed H.R.

1, the Budget Reconciliation Bill, into law.

The legislation includes several changes to federal tax law that generally allow for more favorable deductibility of certain business expenses beginning in 2025, including the restoration of immediate expensing of domestic R&D expenditures, reinstatement of 100% bonus depreciation, and more favorable rules for determining the limitation on business interest expense.

These changes were reflected in the income tax provision for the year ended December 31, 2025.

As the result of the Company maintaining a full valuation allowance against its U.S.

federal and state deferred tax assets, the changes introduced by this legislation did not result in a material impact to the Company’s income tax provision or deferred tax balances for the current reporting period.

The Company will continue to monitor the potential future impacts of the legislation, including any changes to its valuation allowance assessment, as further guidance becomes available and as facts and circumstances evolve.

The Company has analyzed its tax positions and has concluded that there were no uncertain positions as of December 31, 2025 and 2024.

A reconciliation of income tax benefit and the amount computed by applying the statutory federal income tax rates of 21% to loss before taxes for the years ended December 31, 2024 and 2023, respectively, as follows:

Year Ended December 31,

Income taxes at statutory rate 21.00 % 21.00 %

Increase (decrease) resulting from:

State income tax 3.27 4.00

A reconciliation of income tax expense computed at the statutory federal tax rate to income taxes as reflected in the financial statements is as follows:

December 31, 2025

federal statutory rate 21.0 % $ ( 17,595 )

Research and development credit 2.5 ( 2,115 )

Changes in valuation allowances ( 18.1 ) 15,174

Stock compensation ( 4.7 ) 3,923

Other items ( 0.7 ) 613

Total 0.0 % $ —

December 31, 2024

Presented under prior guidance

federal statutory rate 21.0 %

State taxes, net of federal effect 3.3

Permanent differences ( 1.1 )

Valuation allowance ( 23.50 ) ( 26.53 )

Return to provision 1.06 ( 3.28 )

State rate change ( 0.69 ) ( 1.78 )

FDII Deductions

Tax rate changes ( 0.7 )

Change in valuation allowance ( 23.5 )

FDII deduction —

Provison to return adjustments 1.0

Effective tax rate 0.0 %

During the year ended December 31, 2025, the Company received an ERTC refund of $ 1,402 , which is included in Interest income and other income, net on the Company's Statements of Operations and Comprehensive Loss.

The Company also received a refund of $ 65 , including interest, related to the 2023 tax year.

Contingencies

From time to time, the Company has been and may again become involved in legal proceedings arising in the course of its business, including product liability, intellectual property, securities, civil tort, and commercial litigation, and environmental or other regulatory matters.

Kentucky Litigation - Humana

Indivior Inc, Indivior Solutions Inc., Indivior PLC, Reckitt Benckiser Group plc, Reckitt Benckiser Healthcare (UK) Ltd., and Aquestive Therapeutics, Inc.

On August 20, 2021, Humana filed a complaint in state court in Kentucky, alleging conspiracy to violate the RICO Act, fraud under state law, unfair and deceptive trade practices under state law, insurance fraud, and unjust enrichment against the Company relating to Indivior’s launch of Suboxone Sublingual Film in 2010.

The Humana action was stayed pending related litigation, and the stay was lifted on October 30, 2023.

The parties to this case reached a settlement on November 27 2024, the terms of which are confidential.

Aquestive had no obligation, cost or liability in the settlement as all were assumed by Indivior.

California Litigation

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On December 5, 2019, Neurelis, Inc.

("Neurelis") filed a lawsuit against the Company in the Superior Court of California, County of San Diego alleging the following three causes of action:

(1) Unfair Competition under California Business and Professional Code § 17200 (“UCL”);

(2) Defamation;

and (3) Malicious Prosecution.

Neurelis filed a First Amended Complaint on December 9, 2019, alleging the same three causes of action.

The Company filed a Motion to Strike Neurelis’s Complaint under California’s anti-SLAPP (“strategic lawsuit against public participation”) statute on January 31, 2020, which Neurelis opposed.

On August 6, 2020, the Court issued an order granting in part and denying in part the Company’s anti-SLAPP motion.

The parties cross-appealed the ruling to the California Court of Appeal.

The appeals court held oral argument on the appeal on October 14, 2021, and issued its ruling on November 17, 2021.

Under the ruling, the court struck the entirety of the malicious prosecution claim and struck portions of the UCL and defamation claims.

On April 12, 2022, Neurelis filed a Second Amended Complaint in response to the Court of Appeal’s decision.

The Second Amended Complaint also added a cause of action for Trade Libel.

On May 3, 2022, the Company filed a "demurrer" challenge to the sufficiency of the allegations of the Second Amended Complaint.

Oral argument on the Company’s motion for attorney fees related to the anti-SLAPP motion and on the Second Amended Complaint and demurer challenge was held on June 17, 2022.

The Court entered an order granting the Company’s motion for attorney fees, awarding $ 156 and ordering Neurelis to pay the fees within 60 days of June 17, 2022.

The Court denied the Company’s demurrer and the parties proceeded with discovery on the claims in the Second Amended Complaint.

The plaintiff filed a motion to file a third amended complaint.

which the Court granted on November 17, 2023.

The Third Amended Complaint alleges additional facts but includes the same claims as the Second Amended Complaint.

Hearings on motions for summary judgement are scheduled for May 16, 2025.

The trial in this matter is scheduled for July 18, 2025.

The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter.

("Neurelis") filed a civil tort lawsuit against the Company in the Superior Court of California, County of San Diego.

In December 2025, the parties reached a mutual out-of-court settlement agreement resolving all claims related to the matter, the terms of which settlement agreement are confidential.

In the settlement agreement, the Company did not concede liability and settled the matter for business reasons.

The Company does not consider this settlement material to its financial condition.

We anticipate that the court will enter in the records an order of dismissal of the lawsuit with prejudice in the first quarter of 2026.

The settlement of the matter was recorded within Selling, general, and administrative expenses on the Company's Statements of Operations and Comprehensive Loss for the year ended December 31, 2025.

The current liability was recorded within Accounts payable and the non-current liability was recorded within Other non-current liabilities on the Company's Balance Sheets as of December 31, 2025.

Neurelis FDA Lawsuit

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Department of Health and Human Services, and certain government officials.

The complaint in this matter alleges that the defendants violated the Administrative Procedure Act by approving Aquestive’s NDA for Libervant for ARS patients aged between two and five years, and asks the Court to vacate that approval and enjoin the defendants from approving Libervant for this pediatric patient population until January 10, 2027, the scheduled date for the expiration of the U.S.

orphan drug market exclusivity granted by the FDA to the Valtoco nasal spray product of Neurelis.

Aquestive intervened in this litigation to defend the approval of Libervant for this ARS pediatric patient population and, on June 25, 2024, the Court entered a scheduling order governing further proceedings in the case.

Pursuant to that order, Neurelis filed a motion for summary judgment on August 19, 2024;

Aquestive and the federal defendants each filed their own cross-motions for summary judgment and opposed Neurelis’s motion for summary judgment on September 18, 2024.

Neurelis filed its combined reply brief in support of its motion for summary judgment and in opposition to the defendants’ cross-motions on October 9, 2024, and Aquestive and the federal defendants filed their closing briefs on October 30, 2024.

Following the FDA's award of ODE to Libervant for ARS patients between two and five years of age, Neurelis filed a motion for preliminary injunction requesting an expedited order to vacate FDA's approval and enjoining the sale of Libervant.

On February 14, 2025, the Court ruled in favor of Neurelis, granting its summary judgment motion, and against the FDA's and Aquestive's cross-motions for summary judgment.

In an accompanying opinion, the Court directed the FDA to vacate the approval of Libervant.

Because the Court entered a final appealable judgment in favor of Neurelis, Neurelis' motion for an expedited preliminary injunction was denied as moot by the Court.

On February 18, 2025, Aquestive filed an appeal of the Court's decision with the U.S.

The complaint in this matter alleges that the defendants violated the Administrative Procedure Act by approving the Company's NDA for Libervant for ARS patients aged between two and five years, and asked the Court to vacate that approval and enjoin the defendants from approving Libervant for this pediatric patient population until January 10, 2027, the scheduled date for the expiration of the U.S.

orphan drug market exclusivity (ODE) granted by the FDA to the Valtoco nasal spray product of Neurelis (the "ODE Expiration").

The Company intervened in this litigation to defend the approval of Libervant for this ARS pediatric patient population.

Following submission of briefs and filings of respective motions by the parties for summary judgment, on February 14, 2025, the Court entered a final appealable judgment in favor of Neurelis, and against the FDA's and the Company's cross-motions for summary judgment, and directed the FDA to vacate the approval of Libervant.

On February 18, 2025, the Company filed an appeal of the District Court's decision with the U.S.

Circuit Court of Appeals for the District of Columbia (the "DC Appellate Court") and, on the same day, filed an emergency motion with the District Court to stay its order pending a decision on the appeal with the DC Appellate Court.

The District Court set a scheduling order governing filings of all briefs on the motion for stay, ending on March 5, 2025.

No dates have been set for arguments on the stay of the District Court's order or proceedings on the appeal at the DC Appellate Court.

The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter.

The District Court denied the motion for a stay.

On March 27, 2025, the DC Appellate Court denied the Company's emergency motion for stay.

The FDA filed an appeal of the District Court's decision to the DC Appellate Court and the Company withdrew its appeal.

As a result of the District Court's ruling, the FDA converted the approval of Libervant to a "tentative approval" and the Company has ceased marketing activities in the United States.

After a delay of the proceedings at the DC Appellate Court caused by the government shutdown beginning in October 2025, on November 21, 2025, the DC Appellate Court entered a schedule for briefing and oral arguments on the appeal.

Subsequently, on February 3, 2026, Congress adopted and the President signed into law legislation that amended the Orphan Drug Act to provide that ODE applies only to the extent a subsequent applicant seeks approval for the same approved use or indication within the designated rare disease or condition to which the ODE applies.

As applied, this legislation would confirm the FDA's long-standing interpretation of the Orphan Drug Act and its authority to approve another sponsor’s orphan drug for a different use or indication than that of an approved drug with ODE, such as the FDA's prior approval of Libervant for ARS patients aged between two and five years.

On February 16, 2026, the Company filed a motion with the DC Appellate Court requesting that the DC Appellate Court order all parties to submit simultaneous briefs regarding appropriate next steps regarding this legislation and its intended application to this case, including the possibility of a summary disposition of the matter by the DC Appellate Court.

On February 18, 2026, Neurelis filed a brief opposing the Company's motion.

On the DC Appellate Court's own motion filed on February 17, 2026, the DC Appellate Court suspended briefing by the parties in this case pending further order from the court.

On March 2, 2026, the DC Appellate Court entered an order directing the parties to address their positions on the effect on the appeal resulting from the amendment to the Orphan Drug Act recently enacted by March 20, 2026.

The Company is not able to determine or predict the ultimate outcome of these proceedings or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter or whether the FDA will grant U.S.

market access to Libervant for ARS patients aged between two and five years in advance of the ODE Expiration.

Suboxone Product Liability Litigation

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Discovery is underway and no trial date has been set in the MDL matter.

The Company's motion to dismiss the MDL matter was granted as to all claims by plaintiffs except design defect claims.

The Company's motion to dismiss the MDL matter was granted as to all claims against Aquestive by plaintiffs except design defect claims and claims for punitive damages.

The Company is not able to determine or predict the ultimate outcome of this litigation or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter.

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Subsequent Events

Utilization of the At-The-Market Facility

In the period subsequent to December 31, 2024 through March 5, 2025, the Company sold 7,457,627 shares under its ATM facility, which generated net proceeds of approximately $ 21,400 net of commissions of $ 605 .

The remaining authorized balance of the ATM facility was $ 78,000 as of March 5, 2025.

On January 30, 2026, the Company received a CRL from the FDA for the NDA seeking approval of Anaphylm (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 33kg or more (approximately 66 pounds) that focused on administration and labeling guidance.

The FDA cited deficiencies in the Anaphylm HF validation study including instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis.

To resolve the FDA’s concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling, and plans to conduct a new HF validation study with these modifications.

Due to the requirements related to HF, FDA's clinical pharmacology division requested a single PK study to understand the impact of any modifications to packaging and labeling.

The Agency indicated that the HF and PK studies can be conducted in parallel.

No additional studies were requested in the CRL.

The Company also plans to further address potential tolerability issues in its resubmission.

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.

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.

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 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 $ 5.0 million 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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures