ADIL Adial Pharmaceuticals Inc

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 2024.

Cary Claiborne, President and Chief Executive Officer of Adial, stated, “I’m proud of the important progress we have made during the second quarter of 2024 in advancing AD04, our lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD). In June we initiated a pharmacokinetics study of AD04. The final patient completed dosing in the second cohort in August, marking a significant milestone for us. We expect to report topline results from the study during the fourth quarter of 2024. Completion of this study will satisfy a key requirement of the FDA guidance we received as well as inform the study design for the planned Phase 3 clinical trial of AD04. We believe that this will position us more favorably in our ongoing conversations with potential partners.”

The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and will compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg, with or without food, against a reference standard product.

“Furthermore, we entered into a collaboration agreement with Boudicca Dx, a global precision medicine testing accelerator, who will support and advise on the development plan of our companion diagnostic genetic test (CDx) to help ensure compliance with FDA guidelines. Receiving input from the FDA on our CDx plan for the US will assist in clinical success as well as in our next interaction with the FDA on our Phase 3 trial. Overall, we are taking the essential measures to provide us with the greatest probability of success during the Phase 3 trial. We look forward to reporting the pharmacokinetic study results during the fourth quarter and swiftly commencing our Phase 3 trial of AD04,” concluded Mr. Claiborne.

Other Developments

Patents

On July 31, 2024, Adial announced filing a new patent application to protect core assets and extend intellectual property on core technologies to 2044.

Publications

On June 20, 2024, Adial announced the publication of a leading peer-reviewed journal supporting the potential efficacy of AD04 as a precision medicine for the treatment of AUD. The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company’s lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants. The publication is available via Open Access at: https://www.ejinme.com/article/S0953-6205(24)00240-1/fulltext

On April 10, 2024, Adial announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company’s lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company’s prior Phase 3 clinical trial. The publication is available via Open Access at: https://www.ejinme.com/article/S0953-6205(24)00123-7/fulltextSecond Quarter 2024 Financial Results

• Cash and cash equivalents were $3.3 million as of June 30, 2024, compared to $2.8 million as of December 31, 2023. Following the end of the quarter, the Company received total gross proceeds of approximately $3.8 million from utilization of its at-the-market facility. Including the proceeds from at-the-market facility, the Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2025 based on current commitments and development plans.
• Research and development expenses increased by approximately $583 thousand in the three months ended June 30, 2024, compared to the three months ended June 30, 2023. This change was due to an increase of approximately $526 thousand in clinical trial expenses with the initiation of a pharmacokinetics study during the quarter, and an increase of approximately $80 thousand in chemistry, manufacturing, and controls expenses for provision of drug product used in the study.
• General and administrative expenses increased by approximately $228 thousand in the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The increase compared to the prior year’s quarter was primarily driven by one-time gains recognized in the prior year quarter associated with the Purnovate sale, which lowered expense.
• Net Loss was $2.5 million for the three months ended June 30, 2024, compared to a net income of $1.1 million for the three months ended June 30, 2023. Net Income for the second quarter of 2023 included a gain of $2.6 million resulting from the Purnovate Sale completed in June of 2023. Excluding the prior year’s gain, Loss from Continuing Operations increased by $948 thousand, which was driven by the increases in R&D and G&A expenses described above.

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.

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 reporting topline results from the pharmacokinetics study of AD04 during the fourth quarter of 2024, the study satisfying a requirement of the FDA guidance the Company received as well as aiding in optimizing the study design for the planned Phase 3 clinical trial of AD04, Boudicca Dx ensuring compliance with FDA guidelines, receiving input from the FDA on the Company’s CDx plan for the US assisting in clinical success as well as aiding in the Company’s next interaction with the FDA on its Phase 3 trial, taking the essential next steps to provide the Company with the greatest probability of success during the Phase 3 trial while expanding potential partner opportunities, reporting the pharmacokinetic study results during the fourth quarter and swiftly commencing the Company’s Phase 3 trial of AD04, existing cash and cash equivalents funding operating expenses into the second half of 2025 based on current commitments and 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, 2023, 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: ADIL@crescendo-ir.com