ADIAL PHARMACEUTICALS, INC.

Current report

We could lose our listing on the Nasdaq Capital Market if our stockholders’ equity does not meet Nasdaq requirements or if we do not comply with other Nasdaq requirements, including if we do not receive conditional approval from Nasdaq of our Initial Listing Application prior to our receipt of stockholder approval of the conversion of shares of our Series A Preferred Stock. The loss of our Nasdaq listing would likely have an adverse effect on the liquidity and market price of our common stock.

Current report

Pursuant to the Nasdaq continued listing rules, we are currently required to maintain stockholders’ equity in excess of $2.5 million. Our stockholders’ equity as of June 30, 2026, as reported in this Quarterly Report on Form 10-Q, does not meet Nasdaq rules for continued listing of our stock on the Nasdaq Capital Market, LLC (“Nasdaq”). We expect to receive a deficiency notice to this effect from Nasdaq with the opportunity to present a plan to Nasdaq for regaining compliance. Additionally, Nasdaq Listing Rule 5110 requires that the Company submit, and Nasdaq approve, a Nasdaq Listing Application prior to the approval by our stockholders of a change of control pursuant to Nasdaq Listing Rule 5635(b). We currently expect that the receipt of stockholder approval of the conversion of our shares of Series A Preferred Stock, together with certain other expected changes to our management team and board of directors and other factors, will result in a change of control under Nasdaq rules.

Current report

We currently believe that we will exceed the $2.5 million stockholder’s equity continued listing requirement at such time that we receive stockholder approval of the conversion of our Series A Preferred Stock and that we will be able take the necessary actions to obtain conditional approval of our Initial Listing Application from Nasdaq prior to our 2026 Annual Meeting of Stockholders; however, no assurances can be provided that we will satisfy such requirements or be able to obtain the conditional approval of our Initial Listing Application from Nasdaq prior to our 2026 Annual Meeting of Stockholders.

Current report

A delisting of our Common Stock would have an adverse effect on the liquidity and market price of our Common Stock and on our ability to raise additional capital in the public markets. In the event of a delisting from the Nasdaq Capital Market, our common stock would likely be traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than exchange-listed stocks. Accordingly, our common stock would likely be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than exchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed.

Current report

We have identified a material weakness in our internal controls, and we cannot provide assurances that this weakness will be effectively remediated or that additional material weaknesses will not occur in the future

Current report

If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead to a decline in our stock price. Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a- 15(f) under the Exchange Act. During the preparation of our financial statements for the second quarter of 2026, management identified a material weakness in internal control over financial reporting related to the accounting and financial reporting of the non-routine, complex transactions associated with the Transaction. While we plan to take remedial action to address the material weakness, we cannot provide any assurance that such remedial measures, or any other remedial measures we take, will be effective. If we fail to maintain effective internal control over financial reporting, we may not be able to accurately report our financial results, detect or prevent fraud, or file our periodic reports in a timely manner, which may, among other adverse consequences, cause investors to lose confidence in our reported financial information and lead to a decline in our stock price. In addition, a material weakness will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are designed and operating effectively. Although management believes that the material weakness will be remediated in the near future there can be no assurance that the deficiencies will be remediated at such time or that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.

Current report

Pursuant to the terms of the Merger Agreement, the Purchase Agreement and the Exchange Agreements, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series A Preferred Stock into shares of our common stock, the exercise of all of the Assumed Options, the exercise of all of the Initial Closing Pre-Funded Warrants and the exercise of all of the Milestone Warrants. We cannot guarantee that our stockholders will approve these matters, and if they fail to do so we may be required to settle certain shares of our Series A Preferred Stock in cash and continue to solicit our stockholders, which could be time-consuming and costly and adversely affect our financial condition.

Current report

Under the terms of the Merger Agreement, the Purchase Agreement and the Exchange Agreements, as promptly as practicable following the date of the Merger Agreement, we are required to call and hold a meeting of our stockholders to obtain the requisite approval from our stockholders, in accordance with Nasdaq Stock Market Rules, for, among other things: (i) the conversion of the shares of our Series A Preferred Stock into shares of common stock, (ii) the exercise of the Assumed Options by the holders thereof, (iii) the exercise of the Initial Closing Pre-Funded Warrants by the holders thereof, (iv) the exercise of the Milestone Warrants by the holders thereof, (v) the amendment of our certificate of incorporation to increase the number of shares of common stock authorized for issuance thereunder to 500,000,000 shares, (vi) the adoption of a new 2026 Equity Incentive Plan and (vii) the adoption of a new 2026 Employee Stock Purchase Plan (collectively, the “Transaction Stockholder Matters”). If we fail to have enough shares present in person or by proxy to constitute a quorum, fail to obtain the required vote on the Transaction Stockholder Matters and/or the Nasdaq Listing Application is not approved, we will be required to adjourn the 2026 Annual Meeting one or more times for up to 30 days per adjournment. If stockholder approval of the Transaction Stockholder Matters or approval of the Nasdaq Listing Application are still not obtained following such adjournment(s), we will be obligated to continue soliciting stockholder approval at subsequent annual or special meetings of our stockholders, held at intervals of no more than six months, until such approvals are obtained, which would be time consuming and costly.

Current report

There can be no assurance that our stockholders will approve the Transaction Stockholder Matters.

Current report

Additionally, if the conversion of the shares of our Series A Preferred Stock into shares of our common stock is not approved by the date that is six months following the initial issuance date of the Series A Preferred Stock, the holders of the Series A Preferred Stock would be entitled to require us to settle the shares of our common stock underlying the Series A Preferred Stock for cash at a price per share equal to the fair value of our common stock at such time as described in the Certificate of Designation. If we are forced to cash settle a significant amount of the shares of our common stock underlying the Series A Preferred Stock, it could materially affect our results of operations, business and financial condition.

Current report

Pursuant to the Merger Agreement, in order to permit the waiver of the beneficial ownership limitations applicable to the Series A Preferred Stock and take other actions following the consummation of the Merger, which would constitute a “change of control” under Nasdaq Listing Rule 5110(a), we are required to use our reasonable best efforts to file the Nasdaq Listing Application. The Nasdaq Listing Application must be conditionally approved prior to the date of our stockholder meeting to approve the Transaction Stockholder Matters. If we fail to meet the Nasdaq listing requirements and Nasdaq does not approve the Nasdaq Listing Application, we will be required to adjourn our stockholder meeting to approve the Transaction Stockholder Matters one or more times for up to 30 days per adjournment, continue to use our reasonable best efforts to obtain approval of the Nasdaq Listing Application and to continue soliciting stockholder approval of the Transaction Stockholder Matters at subsequent annual or special meetings of our stockholders, held at intervals of no more than six months, until such approval and the approval of the Transaction Stockholder Matters are obtained, which would be time consuming and costly. Additionally, if the conversion of the shares of our Series A Preferred Stock into shares of common stock is not approved by the date that is six months following the initial issuance date of the Series A Preferred Stock, the holders of the Series A Preferred Stock would be entitled to require us to settle their shares of Series A Preferred Stock for cash at a price per share equal to the fair value of the Series A Preferred Stock at such time as described in the Certificate of Designation. If we are forced to cash settle a significant amount of the shares of our common stock underlying the Series A Preferred Stock, it could materially affect our results of operations, business and financial condition. We cannot assure you that we will be able to meet Nasdaq’s initial listing standards. Furthermore, if we fail to obtain approval of the Nasdaq Listing Application, we may be unable to execute on our plans for the Company following the Merger, which could materially affect our results of operations, business and financial condition.

Current report

If certain proposals are not approved by stockholders at the 2026 Annual Meeting, certain securities will remain outstanding and unconverted, which could adversely affect the Company and our stockholders.

Current report

Under the terms of the Merger Agreement, we are obligated to obtain stockholder approval for the conversion of all outstanding shares of Series A Preferred Stock issued in the Merger into shares of our common stock, as required by the Nasdaq Listing Rules. Under the terms of the Purchase Agreement and Exchange Agreements, we are obligated to obtain stockholder approval for the exercise of all outstanding issued or issuable Initial Closing Pre-Funded Warrants and the Milestone Warrants as required by the Nasdaq Listing Rules. We are seeking such approval at the 2026 Annual Meeting. If our stockholders do not approve the conversion of the Series A Preferred Stock, the Series A Preferred Stock will remain outstanding and unconvertable, and we are obligated to seek such approval at one or more subsequent stockholders meetings until such approval is obtained, which would result in additional cost and delay. If our stockholders do not approve the exercise of the Initial Closing Pre-Funded Warrants, the Initial Closing Pre-Funded Warrants will remain outstanding and not exercisable, and we are obligated to seek such approval at one or more subsequent stockholders meetings until such approval is obtained. If our stockholders do not approve the exercise of the Milestone Warrants, any Milestone Pre-Funded Warrants and/or Milestone Incentive Warrants issued, if any, will not be exercisable and we will be obligated to seek such approval at subsequent stockholders meetings, resulting in additional cost and delay and we do not believe the PIPE Investors or Azora Noteholders will seek to acquire any Milestone Warrants until stockholder approval of their exercise is obtained. If the conversion of the Series A Preferred Stock is approved, the conversion of all such Series A Preferred Stock will result in the issuance of a maximum of 12,930,617 shares of our common stock, causing dilution to existing holders of our common stock and an increase in the number of shares eligible for resale in the public market. If the exercise of the Initial Closing Pre-Funded Warrant Proposal is approved, the exercise of all such Initial Closing Pre-Funded Warrants issuable will result in the issuance of a maximum of 11,780,948 shares of our common stock, causing dilution to existing holders of our common stock and an increase in the number of shares eligible for resale in the public market. If the issuance and exercise of the Milestone Warrants is approved, the exercise of all such Milestone Pre-Funded Warrants and Milestone Incentive Warrants will result in the issuance of a maximum of 23,561,896 shares of our common stock, causing dilution to existing holders of our common stock and an increase in the number of shares eligible for resale in the public market. We also have a contractual obligation under the Merger Agreement and RRA to register all shares of common stock issuable upon exercise of the Initial Closing Pre-Funded Warrants for resale within 80 days of the closing of th…

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Current report

The market price of our common stock after the Merger may be affected by factors different from those that historically affected the market price of our common stock.

Current report

The business of Azora differs from that of our legacy ADO4 business in important respects, and, accordingly, our results of operations after the Merger, as well as the market price of our common stock, may be affected by factors different from those that historically affected the results of operations of the Company. Additionally, the market price of our common stock may fluctuate significantly following the Merger. Moreover, general fluctuations in stock markets could have a material adverse effect on the market for, or liquidity of, our common stock, regardless of our actual operating performance.

Current report

The Company believes that there are significant benefits that may be realized by the Merger. However, the efforts to realize these benefits will be a complex process and may disrupt our existing operations if not implemented in a timely and efficient manner. The full benefits of the Merger may not be realized as expected or may not be achieved within the anticipated time frame, or at all. Failure to achieve the anticipated benefits of the Merger could adversely affect our business, operating results or financial condition and cause the combined business to not perform as expected.

Current report

Specifically, the following issues, among others, must be addressed to realize the anticipated benefits of the Merger:

Current report

Potential litigation against us could result in substantial costs and divert management’s attention.

Current report

Securities class action lawsuits and derivative lawsuits are often brought against public companies in connection with merger transactions. Even if such lawsuits are unsuccessful, defending against them can result in substantial costs and divert management’s attention.

Current report

Stockholders of the Company may file lawsuits against the Company and/or directors and officers of the Company in connection with the Merger. Potential lawsuits could result in significant costs to the Company, including any costs associated with the indemnification of directors and officers. There can be no assurance that any of the defendants will be successful in the outcome of any potential lawsuits.

Current report

The expected dilution caused by the issuance of our securities in connection with the Transactions may adversely affect the market price of our common stock.

Current report

The expected dilution caused by the issuance of new shares of our common stock in connection with the conversion of the Series A Preferred Stock issued to former Azora stockholders, and the issuance of common stock upon the exercise of the Assumed Options, the Initial Closing Pre-Funded Warrants, the Milestone Warrants either alone or in combination with any negative impact on the market price of our common stock following the release of lock-up restrictions entered by the respective directors, officers and certain stockholders of Azora and the Company in connection with the Merger, may result in fluctuations in the market price of our common stock, including a stock price decrease.

Current report

Risks Related to the Business of Azora

Current report

Azora is a pre-clinical stage company with a limited operating history and its lead product candidate, AT177, has not yet been tested in human clinical trials. There is no assurance that AT177 will successfully advance through clinical development or receive regulatory approval.

Current report

Azora was founded in 2019 and is a pre-clinical stage biopharmaceutical company. Azora’s lead product candidate, AT177, a colon-targeted AhR agonist being developed for the treatment of ulcerative colitis, has not yet been tested in human clinical trials. We expect to file an IND for AT177 and initiate a Phase 1a SAD/MAD study in the first half of 2027, with a proof-of-concept readout in UC patients expected in the first half of 2028. There can be no assurance that the IND will be accepted by the FDA or that AT177 will demonstrate safety or efficacy in clinical trials. Drug development is inherently uncertain, and pre-clinical results may not be predictive of clinical outcomes. Even if clinical trials are initiated, there is a significant risk that AT177 could fail at any stage due to safety concerns, lack of efficacy, manufacturing difficulties or other factors, which would have a material adverse effect on our business, financial condition and results of operations.

Current report

Substantially all of the value of the assets acquired in the Merger is concentrated in Azora’s colon-targeted AhR program. If this program fails, we may not be able to recover the value attributed to Azora in the Merger.

Current report

We have determined that substantially all (greater than 90%) of the fair value of the assets acquired in the Merger is concentrated in a single asset — Azora’s colon-targeted AhR program. Accordingly, the Merger was treated as an asset acquisition for accounting purposes. Because the acquired value is concentrated in a single program, any failure or material setback in the development of AT177 or other product candidates arising from the AhR program would disproportionately impact the combined company and could result in a significant loss of the value attributed to Azora in the Merger. Unlike a diversified pharmaceutical company with multiple product candidates across various stages of development, our post- Acquisition business is substantially dependent on the success of this single program.

Current report

We will require substantial additional capital to fund the clinical development of AT177, and our failure to obtain sufficient funding on acceptable terms could force us to delay, reduce or eliminate our development programs.

Current report

The clinical development of AT177 through Phase 1 studies, proof-of-concept studies, and any subsequent pivotal trials required for regulatory approval will require substantial capital. While the Financing provides initial capital for our operations, including aggregate gross proceeds of approximately $26.8 million from the Initial Closing Pre-Funded Warrants, the receipt of additional proceeds from the Milestone Pre-Funded Warrants and Milestone Incentive Warrants is contingent upon the achievement of specified milestone events and the election of the PIPE Investors and Azora Noteholders to participate in Milestone Closings, which is at their option. There is no assurance that such milestone events will be achieved or that the PIPE Investors or Azora Noteholders will elect to purchase Milestone Warrants. We may need to raise additional capital through equity or debt financings, collaborations, licensing arrangements or other sources, which may not be available on favorable terms, or at all. If we are unable to raise additional capital when needed, we may be required to delay, reduce or eliminate our clinical development programs.

Current report

The market for the treatment of UC is highly competitive, and AT177 may not be able to compete effectively with existing and future therapies.

Current report

The UC therapeutic market, which management has estimated to be approximately $7.5 billion to $10.8 billion, is highly competitive and includes a number of approved therapies, including anti-TNF biologics, anti-integrin therapies, JAK inhibitors, sphingosine 1-phosphate receptor modulators, and IL-23 inhibitors, as well as numerous product candidates in clinical development by companies with greater financial and development resources than ours. AT177’s novel mechanism of action targeting the AhR in the colon is unproven in clinical settings, and there can be no assurance that this approach will prove superior to, or even comparable with, existing or future therapies. Many of our potential competitors have substantially greater financial, technical, human and other resources than we do, more extensive experience in conducting clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products, and established relationships with physicians and patient communities. If we are unable to differentiate AT177 from existing and future competitive therapies, our business and prospects would be materially adversely affected.

Current report

Our intellectual property protection for the AhR program may be insufficient to protect our competitive position, and we may be unable to prevent third parties from using our technology or developing competing products.

Current report

We rely on patent protection, trade secrets and other intellectual property rights to protect the AhR program, including composition-of-matter patent protection through 2042. However, patents provide only limited protection and may not adequately cover our product candidates or prevent competitors from designing around our patents. Patent applications may not result in issued patents, and issued patents may be challenged, narrowed, invalidated or circumvented. Moreover, the patent landscape in the pharmaceutical industry is highly complex, and third parties may hold patent rights that could prevent us from developing or commercializing AT177. There can be no assurance that our intellectual property position will be sufficient to provide meaningful commercial protection for AT177 or any other product candidate arising from the AhR program, and any inability to adequately protect our intellectual property could materially adversely affect our competitive position, business and financial condition.

Current report

We are dependent on the continued services of key personnel, including Dr. Matthew Davidson, who is critical to the advancement of the Azora AhR program, and the loss of such personnel could materially harm our business.

Current report

The successful development of the Azora AhR program is substantially dependent on the expertise and continued contributions of key scientific and management personnel, including Matthew Davidson, Ph.D., our Chief Development Officer and a co-founder of Azora, who invented and developed the first FDA-approved drug for the skin disease molluscum contagiosum during his prior role as CEO and founder of Verrica Pharmaceuticals, Inc. Dr. Davidson’s scientific expertise and institutional knowledge of the AhR program are critical to advancing AT177 through clinical development. The loss of Dr. Davidson or other key personnel could significantly delay or impair our ability to advance the AhR program. Competition for qualified personnel in the biopharmaceutical industry is intense, and we may not be able to attract or retain qualified scientists and other key personnel on acceptable terms, which could materially adversely affect our business and prospects.

Current report

We may encounter difficulties in managing the integration of Azora’s research and development operations and in scaling our organization to support clinical-stage development activities.

Current report

Following the Merger, we must integrate the research and development operations of Azora and significantly expand its organizational capabilities to support clinical-stage development activities, including, among other things, combining financial, reporting and corporate functions, expanding the number of employees primarily involved in research and development, consolidating administrative and information technology infrastructure, and implementing and maintaining requisite internal controls over financial reporting and disclosure controls and procedures. Prior to the Merger our development activities were focused on its legacy AD04 program, which is at a different stage and involves a different therapeutic area than Azora’s AhR program. The need to pivot our operational focus, combined with the challenges inherent in integrating a newly acquired pre-clinical program, may divert management attention from clinical development activities and increase operating costs. Any failure to successfully manage this transition could delay the development timeline for AT177 and adversely affect our business, financial condition and results of operations.

Previous report

The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into different strategic alternatives. There can be no certainty that any strategic alternative will be completed, be on attractive terms, enhance stockholder value or deliver the anticipated benefits, and successful integration or execution of the strategic alternatives will be subject to additional risks.