ADIL

Completed acquisition of Azora Therapeutics, adding AT177, a fully synthetic, oral, colon-targeted aryl hydrocarbon receptor (“Ahr”) agonist in development for ulcerative colitis, to its pipeline Closed initial $32 million tranche, including the conversion of notes, of an up to $64 million private placement from biotech specialist investors GLEN ALLEN, Va., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”) today provided a business update and reported its financial results for the 2026 second quarter ended June 30, 2026. “The acquisition of Azora Therapeutics and the concurrent financing mark an important inflection point for Adial,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “AT177 establishes a new strategic focus for the Company around a differentiated approach to treating ulcerative colitis, an area where many patients continue to experience inadequate outcomes despite a growing number of therapies. AT177 is built on a mechanism with demonstrated clinical benefit, delivered in a form designed to concentrate activity in the colon, where it matters. Our focus is now on advancing AT177 into the clinic in 2027 and building long-term value for patients and shareholders.” During the quarter, the Company strengthened its financial position by closing the first $32 million tranche, including the conversion of $5.5 million of notes, of an up to $64 million private financing led by biotechnology-focused institutional investors. This financing provides the capital needed to advance AT177 through key clinical development milestones. In parallel, the Company enhanced its board and executive leadership team with experienced pharmaceutical industry veterans with expertise in small molecule drug development. “AhR signaling is a clinically validated pathway with the potential to restore immune homeostasis and epithelial barrier function in ulcerative colitis,” said Matt Davidson, Ph.D., Chief Development Officer and Director of Adial Pharmaceuticals. “AT177 is differentiated by design, a fully synthetic, oral prodrug engineered to release the active AhR agonist in the colon, where disease occurs, while minimizing systemic exposure. We believe this targeted delivery strategy addresses an important limitation of earlier AhR agonists and positions AT177 to capture the promise of localized AhR activation with a potentially better safety profile. With strong progress across our preclinical and CMC programs, we remain on track to file an IND in the first half of 2027.” Second Quarter 2026 Financial Results Cash and cash equivalents were $28.7 million as of June 30, 2026, compared to $4.6 million as of March 31, 2026. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2027. This does not assume receipt of the additional $32 million available under the milestone tranche of the private placement. Research and development expenses decreased by approximately $292 thousand to $440 thousand during the three months ended June 30, 2026, compared to $732 thousand for the three months ended June 30, 2025. This was mainly due to decreased research and development activity as the Company was engaged in merger discussions during the three months ended June 30, 2026 as compared to the same period in 2025. General and administrative expenses increased by approximately $4.3 million to $5.4 million during the three months ended June 30, 2026 compared to $1.2 million for the three months ended June 30, 2025. The increase was mainly due to merger related costs associated with the acquisition of Azora and severance expenses incurred during the three months ended June 30, 2026 as compared to the same period in 2025. Acquired in-process research and development expense was $46.2 million for the three months ended June 30, 2026. This is a non-cash charge representing the fair value of the in-process research and development acquired in the Azora Therapeutics transaction, which was expensed at closing because the acquired in-process research and development has no alternative future use as of the acquisition date. The charge has no effect on the Company’s cash position or on the cash runway described above. Net loss was $52.0 million for the three months ended June 30, 2026, or $(11.25) per basic and diluted share, compared to a net loss of $2.0 million, or $(4.61) per basic and diluted share, for the three months ended June 30, 2025. The increase in net loss was primarily driven by acquired in-process research and development expense of $46.2 million, together with increased general and administrative expenses in the three months ended June 30, 2026 as compared to the same period in 2025. Net loss per share is calculated on 4,621,735 weighted-average shares outstanding and does not give effect to the conversion of the Series A convertible preferred stock, which remains subject to stockholder approval and which would result in 12,930,617 additional shares on an as-converted basis. At June 30, 2026, the Company had a Stockholders’ Deficit of ($38.4) million resulting primarily from the addition of a $23.8 million milestone warrant liability and the classification as mezzanine equity of $38.5 million resulting from the issuance of Series A convertible preferred stock in the merger. The $38.5 million attributable to the Series A convertible preferred stock is expected to be reclassified as equity upon obtaining stockholder approval of its conversion to common stock. The milestone warrant liability resulting from the potential issuance of milestone warrants is a non-cash liability that does not require any cash payment and results from the fact that the number of shares underlying the milestone warrants are not fixed and vary based on investors election of their rights to purchase milestone warrants. Upon the issuance of the milestone warrants, the liability is expected to be converted into equity. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, has historically focused on the development of treatments for addictions and related disorders. In June 2026, the Company acquired Azora Therapeutics, a biopharmaceutical company focused on treating autoimmune diseases, including ulcerative colitis (“UC”). Following the acquisition of Azora, the Company’s focus has shifted to the treatment of serious inflammatory diseases, and its lead program is AT177, which is being studied for the treatment of UC. AT177 is a fully synthetic, patented, oral AhR agonist designed to restore mucosal immune homeostasis at the site of disease with minimal systemic exposure. Its active ingredient is a prodrug of indirubin, the most potent AhR agonist within indigo naturalis, a botanical extract with best-in-category clinical efficacy in UC. In preclinical studies, AT177 demonstrated robust local colonic AhR activation with markedly limited systemic exposure and superior colon-to-systemic selectivity compared to other AhR agonists in development. AT177 is currently in IND-enabling studies, with an investigational new drug (“IND”) filing planned for the first half of 2027, initiation of a Phase 1a single- and multiple-ascending-dose (“SAD/MAD”) clinical trial planned to commence in the second half of 2027, followed by a Phase 1b proof-of-concept study in UC patients. Additional information is available at www.adial.com. Forward-Looking Statements This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include, but are not limited to, statements regarding advancing AT177 into the clinic in 2027; building long-term value for patients and shareholders; the aryl hydrocarbon receptor’s (“AhR”) potential to restore immune homeostasis and epithelial barrier function in UC; the targeted delivery strategy addressing an important limitation of earlier AhR agonists and positioning AT177 to capture the promise of localized AhR activation with a potentially better safety profile; remaining on track to file an IND in the first half of 2027; existing cash and cash equivalents funding operating expenses into the second half of 2027; and initiation of a Phase 1a SAD/MAD clinical trial planned to commence in the second half of 2027, followed by a Phase 1b proof-of-concept study in UC patients; and the reclassification of the Series A convertible preferred stock as equity upon receipt of stockholder approval and the conversion of the warrant liability into equity upon issuance of the milestone warrants. Any forward-looking statements included herein reflect the Company’s current views, and they involve certain risks and uncertainties, including, among others, the Company’s ability to file an IND in the first half of 2027, and to initiate a Phase 1a SAD/MAD clinical trial planned to commence in the second half of 2027, followed by a Phase 1b proof-of-concept study in UC patients; the Company’s ability to pursue its regulatory strategy; the ability to reproduce favorable results in clinical trials; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to develop strategic partnership opportunities and maintain collaborations; the Company’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for specific indications; acceptance of the Company’s product candidates in the marketplace and the successful development, marketing or sale of its products; the Company’s ability to maintain its license agreements; the continued maintenance and growth of the Company’s patent estate and its ability to retain its key employees or maintain the Company’s Nasdaq listing, including to obtain Nasdaq’s conditional approval of an initial listing application that the Company intends to file with Nasdaq in the near term prior to the Company’s 2026 Annual Meeting of stockholders. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Mike MoyerManaging DirectorLifeSci Advisors, LLCPhone: (617) 328-4326Email: [email protected]

GLEN ALLEN, Va., May 11, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the 2026 first quarter ended March 31, 2026. “We are very encouraged by the continued progress we have made in early 2026 to advance AD04 toward late-stage development, particularly in light of several important regulatory and strategic developments that we believe meaningfully strengthen our path forward,” said Cary Claiborne, Chief Executive Officer of Adial. “Most notably, recent Food and Drug Administration (FDA) policy discussions indicating that, in certain scientifically justified cases, approval may be supported by one adequate and well-controlled study together with confirmatory evidence, rather than the traditional requirement of two independent pivotal trials, represents an increased emphasis on the FDA’s existing flexibility in the development landscape. Given that Phase 3 trials are the most capital-intensive stage of development, this evolving framework could substantially reduce costs, improve capital efficiency, and accelerate our potential timeline to NDA submission.” “At the same time, we are seeing growing bipartisan support and regulatory momentum toward more patient-centered clinical trial endpoints in Alcohol Use Disorder (AUD), including measures such as reductions in heavy drinking, cravings, and overall disease severity, where such measures reflect clinically meaningful improvement for patients, rather than strict abstinence alone. This shift is further reinforced by recent Congressional action, including the introduction of bipartisan legislation aimed at expanding access to emerging therapies for veterans suffering from AUD, which supports investigational treatments aligned with the government’s updated definition of recovery, including non-abstinence-based approaches and harm reduction outcomes. These developments are highly aligned with the clinical profile and intended real-world benefit of AD04, and we believe they further validate our approach to developing a differentiated, precision medicine treatment for AUD.” “From a strategic standpoint, we were also pleased to establish a collaboration framework with Molteni Farmaceutici, which represents an important first step toward building a commercial pathway for AD04 in Europe, subject to the execution of a definitive agreement. Molteni’s deep expertise in addiction therapeutics and established infrastructure across European markets make them a strong potential partner as we look to expand AD04’s global reach. In parallel, we continue to strengthen our intellectual property position, including the publication of our international patent application, which, if granted, is expected to extend protection for AD04 through at least 2045, further reinforcing the long-term value of our platform.” “Taken together, these regulatory developments, policy tailwinds, strategic partnerships, and IP advancements position us to advance AD04 with increasing clarity, efficiency, and confidence if we are able to obtain sufficient funding or a strategic partner. We are actively pursuing financing through various potential sources and other strategic plans and strategic alternatives. We believe we have built a strong foundation not only for a successful Phase 3 program, but ultimately for delivering a meaningful, genetically targeted treatment option to patients suffering from Alcohol Use Disorder.” First Quarter 2026 Financial Results Cash and cash equivalents were $4.6 million as of March 31, 2026, compared to $5.9 million as of December 31, 2025. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2026 based on currently committed development plans. Research and development expenses decreased by approximately $314 thousand (42%) to $433 thousand during the three months ended March 31, 2026, compared to $747 thousand for the three months ended March 31, 2025. The decrease was mainly due to decreased CMC and no new data analytics activity in the three months ended March 31, 2026 as compared to the same period in 2025. General and administrative expenses increased by approximately $49 thousand (3%) to $1.6 million during the three months ended March 31, 2026 compared to $1.5 million for the three months ended March 31, 2025. The increase was mainly due to an increase in business development costs incurred in the three months ended March 31, 2026 as compared to the same period in 2025. Net Loss was $2.0 million for the three months ended March 31, 2026, compared to a net loss of $2.2 million for the three months ended March 31, 2025. The decrease in net loss was primarily driven by lower R&D spending and a milestone gain of approximately $150 thousand that was recognized in the three months ended March 31, 2025 which did not occur during the three months ended March 31, 2026. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational product candidate, AD04, is being developed as a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test, pending availability of adequate funds. The Company’s recent ONWARD Phase 3 clinical trial showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding advancing AD04 toward late-stage development; regulatory and strategic developments strengthening the Company’s path forward; the evolving framework of the FDA substantially reducing costs, improving capital efficiency and accelerating the Company’s potential timeline to NDA submission; regulatory developments related to AUD validating the Company’s approach to developing a differentiated, precision medicine treatment for AUD; the Company building a commercial pathway for AD04 in Europe, including by entering into a final definitive agreement to establish a partnership with Molteni covering the commercialization of AD04 in Europe; expanding AD04’s global reach; patent protection for AD04 being extended through at least 2045, further reinforcing the long-term value of its platform; regulatory developments, policy tailwinds, strategic partnerships, and IP advancements positioning the Company to advance AD04 with increasing clarity, efficiency, and confidence if it is able to obtain sufficient funding or a strategic partner; actively pursuing financing through various potential sources and other strategic plans and strategic alternatives; the Company having built a strong foundation not only for a successful Phase 3 program, but ultimately for delivering a meaningful, genetically targeted treatment option to patients suffering from AUD; and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect the Company’s current views, and they involve certain risks and uncertainties, including, among others, the Company’s ability to pursue its regulatory strategy; the Company’s ability to commence its planned Phase 3 clinical trial; the Company’s ability to advance ongoing partnering discussions, including finalizing and entering into a definitive agreement regarding the planned partnership with Molteni; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to develop strategic partnership opportunities and maintain collaborations; the Company’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for specific indications; acceptance of the Company’s product candidates in the marketplace and the successful development, marketing or sale of its products; the Company’s ability to maintain its license agreements; the continued maintenance and growth of the Company’s patent estate and its ability to retain its key employees or maintain the Company’s Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. Adial undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact: Crescendo Communications, LLC David Waldman / Alexandra Schilt Tel: 212-671-1020 Email: [email protected]

GLEN ALLEN, Va., March 06, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the 2025 fiscal year ended December 31, 2025. Key Highlights: Regulatory Progress: Achieved positive clinical study results from the AD04-103 pharmacokinetics (PK) study supporting AD04’s pharmacologic profile and regulatory strategy. Received a positive response from the U.S. Food and Drug Administration (FDA) regarding the Company’s proposed in vitro bridging strategy. Successfully completed its End-of-Phase 2 (EOP2) meeting, advancing regulatory alignment toward Phase 3 development. Expanded Intellectual Property Portfolio: Strengthened IP coverage with multiple U.S. patents issued covering genotype-specific treatment of opioid disorders and expanded genetic-based approaches for treating and diagnosing Alcohol Use Disorder (AUD) and other dependencies. Filed a Patent Cooperation Treaty (PCT) application to protect core assets and extend international exclusivity by 14 years through at least 2045. Strategic Partnerships & Development Support: Engaged Cytel Inc., a global leader in advanced clinical trial design and statistical methodologies, to support AD04 Phase 3 planning. Partnered with Genomind to implement precision medicine testing solutions aligned with genotype-guided therapeutic strategy. U.S.-Based Manufacturing Secured: Secured U.S. manufacturing supply partnerships with Cambrex and Thermo Fisher Scientific for drug substance and drug product supply in support of late-stage development and future commercialization readiness. “2025 was a pivotal year for Adial as we continued to advance AD04 scientifically, strategically, and within an evolving regulatory landscape,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “Our positive AD04-103 pharmacokinetic results, productive End-of-Phase 2 meeting with the FDA, and supportive FDA feedback on our in vitro bridging strategy provided meaningful validation of our clinical and regulatory approach. Engaging Cytel for advanced statistical design and partnering with Genomind for precision medicine testing further strengthens our ability to execute a rigorous and clinically relevant Phase 3 program.” “We were also encouraged by concurrent government and policy developments that align with the scientific rationale and real-world relevance of our development strategy. Bipartisan support in the U.S. Senate for expanding clinical trial endpoints beyond strict abstinence — including outcomes such as reduced cravings and disorder severity — reflects a more patient-centered approach to evaluating addiction therapeutics, consistent with how AD04 is designed to benefit patients. Such support was underscored by a Congressional directive advancing alternative clinical trial endpoints for substance use disorders, which strengthens the regulatory path forward for AD04 and reinforces the importance of broader, clinically meaningful measures in AUD development.” “In addition, recent FDA policy discussion indicating that, in certain scientifically justified cases, approval may be supported by one adequate and well-controlled study plus confirmatory evidence — rather than two independent pivotal trials — highlights a potential shift toward more flexible yet scientifically robust development frameworks. Because Phase 3 trials represent the most capital-intensive stage of development, the ability to pursue a single well-designed pivotal study instead of two could potentially reduce late-stage clinical development costs by tens of millions of dollars, while also lowering associated site, CRO, and operational expenses. A one-study framework could materially improve capital efficiency and shorten development timelines by eliminating the need to initiate and complete a second confirmatory trial, thereby accelerating our potential path toward NDA submission.” “Taken together, these scientific validations, regulatory discussions, and governmental policy signals reinforce the strength of our strategy and the relevance of AD04’s precision medicine approach. With an expanded intellectual property estate, key strategic partnerships, and secured U.S.-based manufacturing, we are well positioned to execute on our mission of delivering meaningful treatments for patients impacted by AUD.” Other Developments Collaborations On March 3, 2026, Adial announced that it entered into a collaboration framework agreement with Molteni Farmaceutici (“Molteni”) for a proposed exclusive partnership covering the commercialization of AD04 in Europe. The collaboration framework, which is subject to execution of a final definitive agreement, outlines the strategic and financial terms of a planned partnership between Adial and Molteni, covering clinical, regulatory, manufacturing, and commercial terms. The anticipated definitive agreement would include upfront and milestone payments, as well as royalties on European net sales payable to Adial, with total potential value estimated at nearly $60 million if AD04 successfully advances and launches in Europe. This marks Adial’s first step toward establishing a European commercial pathway for AD04 in partnership with Molteni, a longstanding specialty pharmaceutical company with extensive capabilities and distribution across Europe. Nasdaq On February 24, 2026, Adial announced that it received notice from Nasdaq on February 23, 2026, that the Company has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company has now successfully resolved its Nasdaq compliance issue and Nasdaq has advised that the matter is now closed. Intellectual Property On January 14, 2026, Adial announced the publication of the international patent application for AD04, filed in July 2024. The patent, once granted, is expected to protect Adial’s core assets by an additional 14 years through at least 2045. Adovate On May 13, 2025, Adial announced that it had received a six-figure development milestone payment from Adovate, LLC (“Adovate”), following the commencement of a Phase 1 clinical trial evaluating Adovate’s lead compound for asthma, ADO-5030. Fiscal Year 2025 Financial Results Cash and cash equivalents were $5.9 million as of December 31, 2025, compared to $3.8 million as of December 31, 2024. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2026 based on currently committed development plans. Research and development expenses decreased by approximately $609 thousand (19%) during the year ended December 31, 2025, compared to the year ended December 31, 2024. The key driver of the decrease was lower clinical activity and lower compensation expense for the year ended December 31, 2025 as compared to the same period in 2024. General and administrative expenses increased by approximately $125,000 (2%) during the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase was mainly due to higher compensation expense for the year ended December 31, 2025 as compared to the same period in 2024. Net Loss was $8.0 million for the year ended December 31, 2025 , compared to a net loss of $13.2 million for the year ended December 31, 2024. The decrease in net loss was primarily driven by lower R&D spending and a one-time non-cash inducement expense of $4.5 million in 2024. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. The Company’s recent ONWARD Phase 3 clinical trial showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding continuing to advance AD04 scientifically, strategically, and within an evolving regulatory landscape, strengthening the Company’s ability to execute a rigorous and clinically relevant Phase 3 program, being encouraged by concurrent government and policy developments that align with the scientific rationale and real-world relevance of the Company’s development strategy, advancing alternative clinical trial endpoints for substance use disorders, strengthening the regulatory path forward for AD04 and reinforcing the importance of broader, clinically meaningful measures in AUD development, the potential shift toward more flexible yet scientifically robust development frameworks, pursuing a single well-designed pivotal study instead of two reducing late-stage clinical development costs by tens of millions of dollars, while also lowering associated site, CRO, and operational expenses, materially improving capital efficiency and shortening development timelines with a one-study framework by eliminating the need to initiate and complete a second confirmatory trial, accelerating the Company’s potential path toward NDA submission, the scientific validations, regulatory discussions, and governmental policy signals reinforcing the strength of the Company’s strategy and the relevance of AD04’s precision medicine approach, being well positioned to execute on the Company’s mission of delivering meaningful treatments for patients impacted by AUD, establishing an exclusive partnership with Molteni covering the commercialization of AD04 in Europe, executing a final definitive agreement regarding the partnership, the definitive agreement including upfront and milestone payments, as well as royalties on European net sales payable to Adial, with total potential value estimated at nearly $60 million if AD04 successfully advances and launches in Europe, the patent for AD04, once granted, protecting the Company’s core assets by an additional 14 years through at least 2045, existing cash and cash equivalents funding operating expenses into the second half of 2026 based on currently committed development plans and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, including our ability to finalize and enter into a definitive agreement regarding the planned partnership with Molteni, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact: Crescendo Communications, LLC David Waldman / Alexandra Schilt Tel: 212-671-1020 Email: [email protected]

GLEN ALLEN, Va., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the third quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We continue to achieve meaningful milestones on our path toward U.S. Food and Drug Administration (FDA) approval and eventual commercialization of AD04, our lead investigational drug, a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). A key highlight of our recent progress was the successful End of Phase 2 (EOP2) meeting with the FDA, where we received valuable guidance on critical elements of our planned adaptive Phase 3 study design — including the target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and validation of both biomarker-positive and biomarker-negative groups.” “We are now implementing the FDA’s recommendations based on this meeting, positioning us to advance confidently toward registrational Phase 3 development. The AD04 program aims to deliver targeted and commercially focused success following approval, specifically for patients who are biomarker-positive for AG+, a subset of the AUD population identified through our proprietary genetic test. The AG+ biomarker is found in approximately 14% of the general population, as supported by large-scale epidemiological studies and previous AD04 clinical trial data.” “We are also encouraged by recent U.S. Senate support for expanding clinical trial endpoints beyond abstinence in evaluating treatments for Alcohol and Substance Use Disorders. The bipartisan Appropriations Committee’s recommendation for the FDA and the National Institute on Drug Abuse (NIDA) to consider additional measures, such as reduced cravings, decreased use, and lowered disorder severity, strongly reinforces our therapeutic approach and patient-centered philosophy. Our AD04 program has always focused on reducing alcohol consumption and cravings rather than enforcing an all-or-nothing abstinence model, and it is encouraging to see legislative recognition of the need for more realistic and compassionate treatment outcomes. This forward-looking perspective aligns with the core of our development strategy and further validates our belief that AD04 is uniquely positioned to benefit from this evolving regulatory environment.” “To further support these efforts, we have partnered with Genomind to develop our precision medicine testing solution. Together, we have completed the analytical validation of a cheek swab collection method to identify eligible patients — a critical step for both clinical trial implementation and future commercial use. This achievement represents a major milestone in our journey toward FDA approval and lays the groundwork for a commercial companion diagnostic test that can be easily performed in a physician’s office or at home. During our recent EOP2 meeting, the FDA also confirmed that use of this test in the Phase 3 study represents a Non-Significant Risk (NSR), meaning an Investigational Device Exemption (IDE) application is not required.” “Collectively, these accomplishments provide strong momentum and confidence as we prepare for our Phase 3 program. They are also driving strategic partnership discussions, which we expect to accelerate as we continue to reach key milestones. We remain committed to disciplined execution and believe AD04 has the potential to become the first genetically targeted therapy approved for AUD — addressing a major unmet medical need with significant commercial opportunity.” Other Developments Intellectual Property On July 9, 2025, Adial announced the filing of an update to the provisional patent application for AD04 which was filed in July 2024, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients (defined as < 10 drinks/drinking day). The patent, once granted, is expected to protect Adial’s core assets out to at least 2045. Third Quarter 2025 Financial Results Cash and cash equivalents were $4.6 million as of September 30, 2025, compared to $5.9 million as of June 30, 2025. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second quarter of 2026 based on currently committed development plans. Research and development expenses decreased by approximately $511 thousand (50%) during the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The key driver of the decrease was lower clinical activity in the three months ended September 30, 2025 as compared to the same period in 2024. General and administrative expenses increased by approximately $63 thousand (5%) during the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The increase was mainly due to the timing of our annual meeting, which occurred in the third quarter in 2025 vs. the fourth quarter in 2024. Net Loss was $1.8 million for the three months ended September 30, 2025, compared to a net loss of $2.2 million for the three months ended September 30, 2024. The decrease in net loss was primarily driven by lower R&D spending. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us ([email protected]) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding FDA approval and eventual commercialization of AD04, implementing the FDA’s recommendations based on the EOP2 meeting, being positioned to advance confidently toward registrational Phase 3 development, the AD04 program delivering targeted and commercially focused success following approval specifically for patients who are biomarker-positive for AG+, AD04 being uniquely positioned to benefit from the evolving regulatory environment in evaluating treatments for Alcohol and Substance Use Disorders, laying the groundwork for a commercial companion diagnostic test that can be easily performed in a physician’s office or at home, accelerating strategic partnership discussions as the Company continues to reach key milestones, remaining committed to disciplined execution, AD04 having the potential to become the first genetically targeted therapy approved for AUD addressing a major unmet medical need with significant commercial opportunity, protecting Adial’s core assets out to at least 2045 with the patent for AD04, once granted, existing cash and cash equivalents funding operating expenses into the second quarter of 2026 based on currently committed development plans and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact: Crescendo Communications, LLC David Waldman / Alexandra Schilt Tel: 212-671-1020 Email: [email protected]

GLEN ALLEN, Va., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the second quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We believe we are at an inflection point in Adial’s journey. With the successful completion of our End of Phase 2 meeting with the Food and Drug Administration (FDA), we have received critical input from the FDA on the clinical and statistical design of our upcoming Phase 3 trial for AD04, our lead investigational drug and a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). This includes agreement on key protocol elements—such as patient population, endpoints, biomarker stratification, and adaptive enrichment strategies—all of which are designed to increase the likelihood of success and support a streamlined path to approval. We expect to receive the official meeting minutes from the FDA within 30 days of the meeting date.” “Additionally, our collaboration with Cytel has been instrumental in shaping a precision-driven, data-informed strategy. By applying advanced machine learning tools and simulation modeling, we’ve identified genetically defined subgroups most likely to benefit from AD04. This enables us to pursue a highly targeted and efficient Phase 3 program, with the potential for interim analyses that could accelerate timelines and increase value creation for shareholders.” “In parallel, we have secured U.S.-based manufacturing agreements with Thermo Fisher Scientific and Cambrex to ensure robust drug product and drug substance supply. These partnerships not only provide the clinical and commercial manufacturing capacity we need but also reduce supply chain risk and strengthen our Chemistry, Manufacturing, and Controls (CMC) position for future NDA submission. The demonstration batches are already complete, and we’re well positioned to initiate registration and validation batches in support of the clinical program.” “We look forward to advancing the clinical program for AD04 and with our progress on the regulatory, clinical, and manufacturing fronts, we are optimistic about achieving a successful outcome in the Phase 3 program. These accomplishments are also catalyzing strategic partnership discussions, which we believe will accelerate now that we’ve met this critical FDA milestone. We remain committed to disciplined execution and believe AD04 has the potential to be the first genetically targeted therapy approved for AUD, a market with enormous unmet need and commercial potential.” Other Developments Nasdaq On July 16, 2025, Adial announced that it received notice from Nasdaq on July 14, 2025 that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain stockholders’ equity of at least $2,500,000. Intellectual Property On July 9, 2025, Adial announced the filing of an update to the provisional patent application for AD04 which was filed in July 2024, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients (defined as < 10 drinks/drinking day). The patent, once granted, is expected to protect Adial’s core assets out to at least 2045. Financing On June 17, 2025, Adial announced a public offering for the purchase and sale of 11,100,000 shares of common stock of the Company (or common stock equivalents in lieu thereof), together with Series D warrants to purchase up to 11,100,000 shares of common stock and Series E warrants to purchase up to 8,325,000 shares of common stock at a combined offering price of $0.3251 per share and accompanying warrants, for aggregate net proceeds of approximately $3.0 million. The Company intends to use the net proceeds of this offering for working capital and general corporate purposes. Second Quarter 2025 Financial Results Cash and cash equivalents were $5.9 million as of June 30, 2025, compared to $2.4 million as of March 31, 2025. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second quarter of 2026 based on currently committed development plans. Research and development expenses decreased by approximately $281 thousand (28%) during the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The key drivers of the decrease were lower contract labor and clinical activity in the three months ended June 30, 2025 as compared to the same period in 2024. General and administrative expenses decreased by approximately $125 thousand (10%) during the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The key drivers of the decrease were lower equity compensation, legal and consulting costs and franchise taxes in the three months ended June 30, 2025 as compared to the same period in 2024. Net Loss was $2.0 million for the three months ended June 30, 2025, compared to a net loss of $2.5 million for the three months ended June 30, 2024. The decrease in net loss was primarily driven by lower R&D and G&A spending along with lower other expenses. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us ([email protected]) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding being at an inflection point in Adial’s journey, the agreement with the FDA on key protocol elements increasing the likelihood of success and supporting a streamlined path to approval, receiving official meeting minutes from the FDA within 30 days of the meeting date, identifying genetically defined subgroups most likely to benefit from AD04, pursuing a highly targeted and efficient Phase 3 program with the potential for interim analyses that could accelerate timelines and increase value creation for shareholders, the manufacturing agreements with Thermo Fisher Scientific and Cambrex ensuring robust drug product and drug substance supply, reducing supply chain risk and strengthening Adial‘s CMC position for future NDA submission, advancing the clinical program for AD04 and achieving a successful outcome in the Phase 3 program, accelerating strategic partnership discussions now that a critical FDA milestone has been met, remaining committed to disciplined execution, AD04 having the potential to be the first genetically targeted therapy approved for AUD, protecting Adial’s core assets out to at least 2045, using the net proceeds of the Company’s public offering for working capital and general corporate purposes, existing cash and cash equivalents funding operating expenses into the second quarter of 2026 based on currently committed development plans and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact: Crescendo Communications, LLC David Waldman / Alexandra Schilt Tel: 212-671-1020 Email: [email protected]

GLEN ALLEN, Va., May 15, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the first quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We made meaningful progress during the first quarter of 2025, completing foundational steps that position us to advance swiftly toward the initiation of our Phase 3 clinical trial for AD04, our lead investigational drug for Alcohol Use Disorder (AUD).” “One of the key achievements this quarter was the successful completion of our pharmacokinetics bridging study, AD04-103, which confirmed that AD04 delivers favorable and consistent bioavailability, with or without food. This reinforces a flexible and patient-friendly dosing regimen that supports real-world use. Following this milestone, we have commenced manufacturing of our clinical trial supply, ensuring we are operationally ready to enter the next stage of development.” “We were also pleased to receive confirmation from the FDA supporting our proposed 505(b)(2) in vitro bridging strategy. This strategy leverages data from the AD04-103 study, along with in vitro dissolution data demonstrating equivalence between the formulation used in our prior Phase 3 ONWARD trial and the planned commercial formulation of AD04. This regulatory alignment represents a significant validation of our development plan and enables a more streamlined and efficient path into our next pivotal study. In parallel, we continue to strengthen our intellectual property portfolio with multiple granted patents that broaden and extend protection around AD04’s formulation, method of use, and its genetically guided patient targeting strategy—further enhancing the value and defensibility of our program.” “Looking ahead, we are preparing for our End of Phase 2 meeting with the FDA in July to finalize key aspects of our Phase 3 trial design and protocol. This engagement represents a pivotal milestone, offering regulatory clarity and ensuring alignment on our development plans. Given the strong progress made across clinical, regulatory, and operational fronts, we believe we are well-positioned to proceed efficiently. The foundation we have built gives us confidence in our ability to advance AD04 through late-stage development and bring a much-needed treatment option to patients living with AUD.” Other Developments Adovate, LLC On May 13, 2025, Adial announced that it has received a six-figure development milestone payment from Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate’s lead compound for asthma, ADO-5030. This milestone payment follows Adovate’s exercise of its option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, as previously disclosed. Under the terms of the agreement with Adovate, Adial is eligible to receive more than $50 million in commercial milestone payments plus an additional $11 million in development and approval milestone payments per compound, for a total consideration of up to $83 million for the first three compounds alone if such milestones are achieved. In addition, Adial is entitled to low single-digit royalties on net sales should the program advance to commercialization. Adial also retains a significant equity stake in Adovate of over 10%, positioning the Company to participate in the long-term upside as the asthma candidate advances through clinical development and toward potential commercialization. Intellectual Property On May 1, 2025, Adial announced patent number 12,274,692 was issued on April 15, 2025, by the United States Patent and Trademark Office covering the administration of AD04, the Company’s investigational drug, as a precision medicine approach for patients with specific genetic markers. The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4, such as the LL genotype of 5-HTTLPR in combination with variations in rs1150226, rs17614942, and rs1176713. Warrants On May 2, 2025, Adial announced its entry into a warrant inducement agreement with an existing healthcare-focused institutional investor of the Company for the immediate exercise of existing Series B Warrants to purchase 1,418,440 shares of the Company’s common stock, par value $0.001 per share, and Series C Warrants to purchase 2,300,000 shares of Common Stock at a reduced exercise price of $0.74 for gross cash proceeds of approximately $2.75 million, before deducting financial advisor fees and other transaction expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes. First Quarter 2025 Financial Results Cash and cash equivalents were $2.4 million as of March 31, 2025, compared to $3.8 million as of December 31, 2024. Including the proceeds from the warrant exercises, the Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025 based on currently committed development plans. Research and development expenses increased by approximately $293 thousand (65%) during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The key drivers of the increase were increased chemistry, manufacturing, and controls (CMC) expenses to develop clinical supplies for the upcoming program and consulting expenses as we continue to progress and advance AD04 to a Phase 3 trial. General and administrative expenses increased by approximately $129 thousand (9%) during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This modest increase was mainly due to higher compensation and consulting. Net Loss was $2.2 million for the three months ended March 31, 2025, compared to a net loss of $6.5 million for the three months ended March 31, 2024. The decrease in net loss was primarily driven by non-cash charges of $4.5 million for an inducement expense in 2024 which was not incurred in 2025 and partially offset by increases in R&D and G&A spending. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us ([email protected]) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding being positioned to advance swiftly toward the initiation of the Phase 3 clinical trial for AD04, the regulatory alignment with the FDA enabling a more streamlined and efficient path into the next pivotal study, continuing to strengthen the Company’s intellectual property portfolio, enhancing the value and defensibility of the Company’s program, preparing for the End of Phase 2 meeting with the FDA in July to finalize key aspects of our Phase 3 trial design and protocol, the engagement with the FDA offering regulatory clarity and ensuring alignment on the Company’s development plans, being well-positioned to proceed efficiently given the strong progress made across clinical, regulatory, and operational fronts, advancing AD04 through late-stage development, bringing a much-needed treatment option to patients living with AUD, positioning the Company to participate in the long-term upside of Adovate as its asthma candidate advances through clinical development and toward potential commercialization, using the net proceeds from the warrant inducement transaction for working capital and other general corporate purposes, existing cash and cash equivalents funding operating expenses into the fourth quarter of 2025 and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: [email protected]