As filed with the Securities and Exchange Commission on September 20, 2023
Registration No. 333-
Delaware | | | 82-3827296 |
(State or other jurisdiction of incorporation or organization) | | | (I.R.S. Employer Identification Number) |
Lori J. Braender Senior Vice President, General Counsel, Chief Compliance Officer & Corporate Secretary 30 Technology Drive 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 for Anaphylm and other product candidates; |
• | risk of our failure to generate sufficient data in our NDA submission for FDA approval of Anaphylm; |
• | risk of our failure to address the concerns identified in the FDA End-of-Phase 2 meeting for Anaphylm; |
• | risk of delays in or the failure to receive FDA approval of Anaphylm, including the risk that the FDA may require additional clinical studies for FDA approval of Anaphylm, and there can be no assurance that we will be successful in obtaining such approval; |
• | risks that the FDA will not approve Libervant for U.S. market access by overcoming the seven year orphan drug market exclusivity of an FDA approved nasal spray product in effect until January 2027, and there can be no assurance that we will be successful in obtaining such approval; |
• | risk of delays in or the failure to receive FDA approval of the NDA for Libervant for patients between two and five years of age, including the risk that the FDA may require additional clinical studies for FDA approval of Libervant for this age group, and there can be no assurance that we will be successful in obtaining such approval; |
• | risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); |
• | risk of our ability to license our proprietary products in the United States or abroad and risks that such product candidates will receive regulatory approval in those licensed territories; |
• | risk of our ability to enter into other commercial transactions with third parties that will support growth of the business and execution of key initiatives; |
• | risk that our manufacturing capabilities will be sufficient to support demand for existing and potential future licensed products in the Unites States and other countries; |
• | risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed; |
• | risk of failure to satisfy all financial and other debt covenants and of any default; |
• | short-term and long-term liquidity and cash requirements, cash funding and cash burn; |
• | risk that we are unable to refinance our current corporate debt on terms and conditions satisfactory to us, or not at all; |
• | risk of eroding market share for Suboxone® and risk of a sunsetting product, which accounts for the substantial part of our current operating revenue; |
• | risk of the rate and degree of market acceptance of our licensed and product candidates in the United States and abroad; |
• | the success of any competing products, including generics; |
• | risk of the size and growth of our product markets; |
• | risks of 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 of unexpected patent developments; uncertainties related to general economic, political, business, industry, regulatory, financial and market conditions and other unusual items; and |
• | other risks and 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 | | | Number | | | Percentage | | | Number | | | Percentage | |||
Armistice Capital, LLC(2) | | | 4,924,000(3) | | | 7.38%(2) | | | 2,750,000 | | | 4,924,000 | | | 7.09%(2) |
(1) | Assumes all Warrant Shares offered by the Selling Stockholder hereby are sold and that the Selling Stockholder buys or sells no additional shares of Common Stock prior to the completion of this offering. |
(2) | The amounts and percentages in the table are provided without regard to the Beneficial Ownership Limitation. |
(3) | Excludes 2,750,000 Warrant Shares underlying the Warrants, which are not exercisable until February 2, 2024, which are also the shares of our Common Stock being registered pursuant the Resale Registration Statement of which this prospectus forms a part. |
• | 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; |
• | 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 Stockholder 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, 2022, filed with the SEC on March 31, 2023; |
• | our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 28, 2023, 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 3, 2023, January 24, 2023, February 7, 2023, March 6, 2023, April 13, 2023, May 31, 2023, June 23, 2023, June 29, 2023 and August 2, 2023, 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 | | | $465.18 |
Accounting fees and expenses | | | $35,000 |
Legal fees and expenses | | | $35,000 |
Printing and miscellaneous expenses | | | $2,000 |
Total | | | $72,465.18 |
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 3.2 to the Current Report on Form 8-K of the Company, as filed on February 7, 2023, 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 (filed as Exhibit 4.1 to the Current Report on Form 8-K of the Company, as filed on August 2, 2023, and incorporated by reference herein). | |
| | Opinion of Dechert LLP. | |
| | Inducement Offer to Exercise Common Stock Purchase Warrants Letter Agreement dated August 1, 2023 (filed as Exhibit 10.1 to the Current Report on Form 8-K of the Company, as filed on August 2, 2023, and incorporated by reference herein). | |
| | 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. |
Item 17. | Undertakings |
| | AQUESTIVE THERAPEUTICS, INC. | ||||
| | | | |||
| | By: | | | /s/ Daniel Barber | |
| | | | Daniel Barber | ||
| | | | President and Chief Executive Officer |
Name and Signature | | | Title | | | Date |
| | | | |||
/s/ Daniel Barber | | | President and Chief Executive Officer and Member of the Board of Directors (Principal Executive Officer) | | | September 20, 2023 |
Daniel Barber | | |||||
| | | | |||
/s/ A. Ernest Toth, Jr. | | | Senior Vice President, Chief Financial Officer (Principal Financial and Accounting Officer) | | | September 20, 2023 |
A. Ernest Toth, Jr. | | |||||
| | | | |||
/s/ Gregory B. Brown, M.D. | | | Director | | | September 20, 2023 |
Gregory B. Brown, M.D. | | |||||
| | | | |||
/s/ John S. Cochran | | | Director | | | September 20, 2023 |
John S. Cochran | | |||||
| | | | |||
/s/ Santo J. Costa | | | Chairman of the Board of Directors | | | September 20, 2023 |
Santo J. Costa | | |||||
| | | | |||
/s/ Julie Krop, M.D. | | | Director | | | September 20, 2023 |
Julie Krop, M.D. | | |||||
| | | | |||
/s/ Timothy Morris | | | Director | | | September 20, 2023 |
Timothy Morris | | |||||
| | | | |||
/s/ Marco Taglietti, M.D. | | | Director | | | September 20, 2023 |
Marco Taglietti, M.D. | |
1095 Avenue of the Americas
New York, NY 10036-6797
+1 212 698 3500 Main
+1 212 698 3599 Fax
www.dechert.com
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Re:
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Registration Statement on Form S-3
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(i)
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the Registration Statement;
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(ii)
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the Company’s Amended and Restated Certificate of Incorporation, as originally filed with the Secretary of State of the State of Delaware on July 27, 2018;
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(iii)
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the Company’s Amended and Restated Bylaws, adopted on February 2, 2023;
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(iv)
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a Certificate of Good Standing with respect to the Company issued by the Secretary of State of the State of Delaware, as of a recent date; and
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(v)
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the resolutions of the board of directors of the Company, relating to, among other things, the authorization and approval of the preparation and filing of the Registration Statement.
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Very truly yours,
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/s/ Dechert LLP
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Security Type
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Security
Class Title |
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Fee
Calculation or Carry Forward Rule |
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Amount
Registered |
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Proposed
Maximum Offering Price Per Unit |
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Maximum
Aggregate Offering Price |
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Fee Rate
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Amount of
Registration Fee |
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Carry
Forward Form Type |
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Carry
Forward File Number |
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Carry
Forward Initial effective date |
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Filing Fee
Previously Paid In Connection with Unsold Securities to be Carried Forward |
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|||||||||
Newly Registered Securities
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Fees to Be Paid
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Equity
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Common stock, par value $0.001 per share(1)
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Rule 457(c)
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2,750,000
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(2)
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$
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1.535
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(3)
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$
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4,221,250
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(3)
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0.00011020
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$
|
465.18
|
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|||||||||||||||||||||
Fees Previously Paid
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N/A
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N/A
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N/A
|
|
|
N/A
|
|
|
|
N/A
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|
|
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N/A
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|
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N/A
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Carry Forward Securities
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Carry Forward Securities
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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Total Offering Amounts
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$
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4,221,250
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$
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465.18
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Total Fees Previously Paid
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-
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Total Fee Offsets
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-
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Net Fee Due
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$
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465.18
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(1)
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Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”), this registration statement also covers such an indeterminate amount of shares of common stock as
may become issuable to prevent dilution resulting from stock splits, stock dividends and similar events.
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(2)
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Represents shares of common stock issuable upon exercise of warrants to purchase common stock offered by the selling stockholder.
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(3)
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Estimated solely for the purpose of calculating the registration fee, based on the average of the high and low prices of the shares of common stock on The Nasdaq Global Market on
September 19, 2023 (such date being within five business days of the date that this registration statement was first filed with the Securities and Exchange Commission, in accordance with Rule 457(c) under the Securities Act).
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