07/09/2026 | Press release | Distributed by Public on 07/09/2026 14:30
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ABOUT THIS PROSPECTUS
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1
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SUMMARY
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2
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RISK FACTORS
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4
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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5
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DESCRIPTION OF THE PRIVATE PLACEMENT
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8
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SELLING STOCKHOLDERS
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9
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USE OF PROCEEDS
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11
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PLAN OF DISTRIBUTION
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12
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LEGAL MATTERS
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14
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EXPERTS
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14
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WHERE YOU CAN FIND MORE INFORMATION
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14
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
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15
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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;
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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;
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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;
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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;
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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;
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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;
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risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm;
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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;
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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;
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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;
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risks associated with the success of any competing products, including generics;
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risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations);
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risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, if approved by the FDA;
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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;
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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;
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risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue;
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risk of default of our debt instruments;
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risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties;
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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;
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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;
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risks associated with intellectual property rights and infringement claims relating to our products;
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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;
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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;
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risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters;
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risk of product recalls and withdrawals;
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risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks;
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risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry;
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risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business;
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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
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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.
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Shares of Common Stock
beneficially owned
prior to the offering
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Shares of
Common
Stock to
be offered
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Shares of Common Stock
beneficially owned
after the offering(1)
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Name of Selling Stockholder(2)
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Number
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Percentage
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Number
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Percentage
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Oaktree-TCDRS Strategic Credit, LLC
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7,872
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*
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7,873
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0
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-
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Oaktree-Forrest Multi-Strategy, LLC
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3,905
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*
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3,906
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0
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-
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Oaktree-TBMR Strategic Credit Fund C, LLC
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2,024
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*
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2,025
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0
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-
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Oaktree-TBMR Strategic Credit Fund F, LLC
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3,269
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*
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3,270
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0
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-
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Oaktree-TBMR Strategic Credit Fund G, LLC
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5,270
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*
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5,271
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0
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-
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Oaktree-TSE 16 Strategic Credit, LLC
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7,301
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*
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7,302
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0
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-
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INPRS Strategic Credit Holdings, LLC
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5,388
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*
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5,389
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0
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Oaktree Specialty Lending Corporation
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26,526
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*
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26,527
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0
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Oaktree Direct Lending Fund Delaware Holdings Non-EURRC, L.P.
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4,584
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*
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4,585
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0
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-
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Oaktree Direct Lending Fund VCOC Delaware Holdings Non-EURRC, L.P.
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1,842
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*
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1,843
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0
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-
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Oaktree Direct Lending Fund Unlevered Delaware Holdings Non-EURRC, L.P.
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3,543
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*
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3,544
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0
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-
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Oaktree Blue Credit 1 Investment Fund, L.P.
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10,972
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*
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10,973
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0
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-
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Oaktree Multi-Strategy Credit Archway Evergreen Fund, L.P.
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2,136
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*
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2,137
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0
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Oaktree LSL Fund Delaware Holdings Non-EURRC, L.P.
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32,676
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*
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32,677
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0
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-
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Oaktree Jalapeno Investment Fund, L.P.
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112,948
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*
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112,949
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0
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-
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*
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Less than 1%
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(1)
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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.
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(2)
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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.
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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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;
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
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distributions of the Warrant Shares by a Selling Stockholder to its partners, members, stockholders, equityholders or other affiliates, including distributions made in-kind;
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an exchange distribution in accordance with the rules of the applicable exchange;
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privately negotiated transactions;
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settlement of short sales;
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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;
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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a combination of any such methods of sale; or
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any other method permitted pursuant to applicable law.
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our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 4, 2026;
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 13, 2026;
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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;
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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
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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.
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