As filed with the Securities and Exchange Commission on June 26, 2026
Registration No. 333-
Delaware | 82-3827296 | ||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) | ||
Thomas A. Zalewski Chief Legal Officer and Chief Compliance Officer Aquestive Therapeutics, Inc. 30 Technology Drive S. Warren, New Jersey 07059 | David S. Rosenthal, Esq. Anna Tomczyk, Esq. Dechert LLP 1095 Avenue of the Americas New York, New York 10036 | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | ||||||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | ||||||
Emerging growth company | ☐ | ||||||||

• | risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm, AQST-108, and our other product candidates; |
• | risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing, including under our “at-the-market” facility and the funding agreement with RTW Investments LP, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, AQST-108 and Libervant should these product candidates be approved by the FDA; |
• | risks related to our existing indebtedness and potential future obligations under our Credit Agreement, including the risk that, should Anaphylm receive FDA approval, our indebtedness will increase substantially, and there is no assurance that revenues from the commercialization of Anaphylm will be sufficient to service or repay such obligations; and that, if Anaphylm does not receive FDA approval, we will be required to maintain larger cash reserves to fund ongoing operations and will not be able to deploy those funds for other purposes; |
• | risks that restrictive covenants contained in our Credit Agreement could limit our operational flexibility, including restrict our ability to incur additional indebtedness or make investments, and impair our ability to raise additional capital when needed; |
• | risk of the impact of our obligations under the Company’s purchase and sale agreement with funds managed by RTW Investments LP and the royalty rights agreements with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations and the payment of interest on our debt; |
• | risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing of the respective NDAs, for Anaphylm, AQST-108, Libervant and other product candidates, or failure to receive FDA approval at all for any of these product candidates; |
• | risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm; |
• | risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm and Libervant; |
• | risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetics and pharmacodynamics (PK/PD) comparability data for FDA approval of Anaphylm; |
• | risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA for Anaphylm, including the concerns raised by the FDA in the CRL and Type A Meeting; |
• | risks associated with the success of any competing products, including generics; |
• | risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); |
• | risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, if approved by the FDA; |
• | risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Libervant and Anaphylm and other product candidates; |
• | risk that our manufacturing capabilities will be insufficient to support demand of our product candidates in the U.S. and abroad, including Anaphylm, if such product candidates should be approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; |
• | risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; |
• | risk of default of our debt instruments; |
• | risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; |
• | risk of the rate and degree of market acceptance in the U.S. and abroad of Anaphylm, AQST-108, Libervant and our other product candidates, should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; |
• | risk associated with the size and growth of our product markets; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; |
• | risks associated with intellectual property rights and infringement claims relating to our products; |
• | risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the United States Patent and Trademark Office (PTO) or, if issued, will be sufficient to provide long-term commercial success of these product candidates; risk of unexpected patent developments; |
• | risk of legislation and regulatory actions and changes in laws or regulations affecting our business, including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; |
• | risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; |
• | risk of product recalls and withdrawals; |
• | risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; |
• | risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; |
• | risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; |
• | risks and uncertainties related to general economic, political (including the Ukraine, Israel and Iran wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of government tariffs and other trade restrictions; and |
• | other uncertainties affecting us described in the “Risk Factors” section and in other sections included in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K and our other filings with the SEC. |
Shares of Common Stock beneficially owned prior to the offering | Shares of Common Stock to be offered | Shares of Common Stock beneficially owned after the offering(1) | |||||||||||||
Name of Selling Stockholder(2) | Number | Percentage | Number | Percentage | |||||||||||
Oaktree-TCDRS Strategic Credit, LLC | 7,872 | * | 7,873 | 0 | — | ||||||||||
Oaktree-Forrest Multi-Strategy, LLC | 3,905 | * | 3,906 | 0 | — | ||||||||||
Oaktree-TBMR Strategic Credit Fund C, LLC | 2,024 | * | 2,025 | 0 | — | ||||||||||
Oaktree-TBMR Strategic Credit Fund F, LLC | 3,269 | * | 3,270 | 0 | — | ||||||||||
Oaktree-TBMR Strategic Credit Fund G, LLC | 5,270 | * | 5,271 | 0 | — | ||||||||||
Oaktree-TSE 16 Strategic Credit, LLC | 7,301 | * | 7,302 | 0 | — | ||||||||||
INPRS Strategic Credit Holdings, LLC | 5,388 | * | 5,389 | 0 | — | ||||||||||
Oaktree Specialty Lending Corporation | 26,526 | * | 26,527 | 0 | — | ||||||||||
Oaktree Direct Lending Fund Delaware Holdings Non-EURRC, L.P. | 4,584 | * | 4,585 | 0 | — | ||||||||||
Oaktree Direct Lending Fund VCOC Delaware Holdings Non-EURRC, L.P. | 1,842 | * | 1,843 | 0 | — | ||||||||||
Oaktree Direct Lending Fund Unlevered Delaware Holdings Non-EURRC, L.P. | 3,543 | * | 3,544 | 0 | — | ||||||||||
Oaktree Blue Credit 1 Investment Fund, L.P. | 10,972 | * | 10,973 | 0 | — | ||||||||||
Oaktree Multi-Strategy Credit Archway Evergreen Fund, L.P. | 2,136 | * | 2,137 | 0 | — | ||||||||||
Oaktree LSL Fund Delaware Holdings Non-EURRC, L.P. | 32,676 | * | 32,677 | 0 | — | ||||||||||
Oaktree Jalapeno Investment Fund, L.P. | 112,948 | * | 112,949 | 0 | — | ||||||||||
* | Less than 1% |
(1) | Assumes all Warrant Shares offered by the Selling Stockholders hereby are sold and that the Selling Stockholders buy no additional shares of Common Stock prior to the completion of this offering. |
(2) | The sole manager of each of Oaktree-TCDRS Strategic Credit, LLC, Oaktree-Forrest Multi-Strategy, LLC, Oaktree-TBMR Strategic Credit Fund C, LLC, Oaktree-TBMR Strategic Credit Fund F, LLC, Oaktree-TBMR Strategic Credit Fund G, LLC, Oaktree-TSE 16 Strategic Credit, LLC, and INPRS Strategic Credit Holdings, LLC is Oaktree Capital Management, L.P. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the Warrant Shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | distributions of the Warrant Shares by a Selling Stockholder to its partners, members, stockholders, equityholders or other affiliates, including distributions made in-kind; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of the Warrant Shares at a stipulated price per security; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 4, 2026; |
• | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 13, 2026; |
• | our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 24, 2026, to the extent incorporated by reference in Part III of the Form 10-K; |
• | our Current Reports on Form 8-K filed with the SEC on January 9, 2026, March 4, 2026, March 20, 2026, May 13, 2026 and June 10, 2026, to the extent the information in such reports is filed and not furnished; and |
• | the description of our Common Stock contained in our Registration Statement on Form 8-A, filed with the SEC on July 20, 2018, including any amendments or reports filed for the purposes of updating this description. |
Item 14. | Other Expenses of Issuance and Distribution |
SEC registration fee | $156.14 | ||
Accounting fees and expenses | $35,000 | ||
Legal fees and expenses | $35,000 | ||
Printing and miscellaneous expenses | $2,000 | ||
Total | $72,156.14 | ||
Item 15. | Indemnification of Officers and Directors |
• | transaction from which the director derives an improper personal benefit; |
• | act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
• | unlawful payment of dividends or redemption of shares; or |
• | breach of a director's duty of loyalty to the corporation or its stockholders. |
Item 16. | Exhibits and Financial Statement Schedules |
Exhibit Number | Description of Document | ||
Amended and Restated Certificate of Incorporation of Aquestive Therapeutics, Inc., dated as of July 27, 2018 (filed as Exhibit 3.1 to the Current Report on Form 8-K of the Company, as filed on July 27, 2018, and incorporated by reference herein). | |||
Amended and Restated Bylaws of Aquestive Therapeutics, Inc. (filed as Exhibit 3.1 to the Current Report on Form 8-K of the Company, as filed on October 16, 2024, and incorporated by reference herein). | |||
Form of Common Stock Certificate of Aquestive Therapeutics, Inc. (filed as Exhibit 4.1 to the Registration Statement on Form S-1 of the Company (File No. 333-225924), as filed on June 27, 2018, and incorporated by reference herein). | |||
Form of Warrant. | |||
Opinion of Dechert LLP. | |||
Warrant Issuance Agreement, dated as of May 12, 2026, between Oaktree Capital Management, L.P. and Aquestive Therapeutics, Inc. | |||
Credit Agreement and Guaranty, dated as of May 12, 2026, by and among Aquestive Therapeutics, Inc., the guarantors from time to time party thereto, the lenders from time to time party thereto, and Oaktree Fund Administration, LLC. | |||
Security Agreement, dated as of May 12, 2026, by and among Aquestive Therapeutics, Inc., the borrower’s subsidiaries having acceded thereto pursuant to Section 24, and Oaktree Fund Administration, LLC. | |||
Consent of KPMG LLP. | |||
Consent of Dechert LLP (included in its Opinion filed as Exhibit 5.1 hereto). | |||
Powers of Attorney (included on signature page). | |||
Filing Fee Table. | |||
* | Filed herewith. |
† | Certain portions of this exhibit have been omitted in accordance with Item 601(b)(10)(iv) of Regulation S-K because the omitted information is (i) not material and (ii) the registrant customarily and actually treats that information as private or confidential. The registrant agrees to furnish supplementally an unredacted copy and its materiality and privacy or confidentiality analyses to the SEC upon its request. |
Item 17. | Undertakings |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act to any purchaser: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: (i) any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; (ii) any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; (iii) the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and (iv) any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(6) | That, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(7) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
AQUESTIVE THERAPEUTICS, INC. | ||||||
By: | /s/ Daniel Barber | |||||
Daniel Barber | ||||||
President and Chief Executive Officer (Principal Executive Officer) | ||||||
Name and Signature | Title | Date | ||||
/s/ Daniel Barber | President, Chief Executive Officer and Member of the Board of Directors (Principal Executive Officer) | June 26, 2026 | ||||
Daniel Barber | ||||||
/s/ A. Ernest Toth, Jr. | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | June 26, 2026 | ||||
A. Ernest Toth, Jr. | ||||||
/s/ Gregory B. Brown | Chairman of the Board of Directors | June 26, 2026 | ||||
Gregory B. Brown, M.D. | ||||||
/s/ Abigail L. Jenkins | Member of the Board of Directors | June 26, 2026 | ||||
Abigail L. Jenkins | ||||||
/s/ John S. Cochran | Member of the Board of Directors | June 26, 2026 | ||||
John S. Cochran | ||||||
/s/ Julie Krop | Member of the Board of Directors | June 26, 2026 | ||||
Julie Krop, M.D. | ||||||
/s/ Marco Taglietti | Member of the Board of Directors | June 26, 2026 | ||||
Marco Taglietti, M.D. | ||||||
/s/ Timothy Morris | Member of the Board of Directors | June 26, 2026 | ||||
Timothy Morris | ||||||