Form 8-K - Current report - Item 3.01 Item 9.01

Adial Pharmaceuticals Inc

Announcement: ADIL 8-K Special Filing

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, has reported their financial results for the first quarter of 2023 as well as given a business update. The company reported cash and cash equivalents of $2.3 million. Meanwhile, they have conducted meetings with regulatory agencies across the US and Europe for their regulatory strategy. They are waiting for final meeting minutes to be received, following which they plan to advance their ongoing partnering discussions. The Keswick Group has been engaged to assist in advancing partnering activities. The company has sold the assets and business of its subsidiary Purnovate to Adovate, allowing Adial Pharmaceuticals to focus exclusively on advancing AD04 through regulatory approval potentially. In that deal, Adial Pharmaceuticals received an upfront payment of $450,000 on the notification date. They will receive an additional $0.9 million for Purnovate expenditures incurred and paid by them after December 1, 2022. They also expect to receive up to $83 million in development and approval milestones for each compound. Additionally, they will receive a single-digit royalty and a 19.9% equity stake in Adovate. On the development side, Adial Pharmaceuticals is working on AD04, which could potentially treat opioid use disorder, gambling, and obesity. Overall, the financial report shows a positive outlook for the company, with strategic partnering activities and regulatory meetings taking place.

Form 8-K - Current report - Item 2.02 Item 9.01

PRESS RELEASE, ISSUED BY ADIAL PHARMACEUTICALS, INC. ON MAY 12, 2023

$ADIL Reports Positive Q1 Financial Results and Advances Regulatory Strategy and Partnership Discussions

PART 1: Analysis of Performance

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapeutics for the treatment or prevention of addiction and related disorders. During the period, the company's key focus was on the development of AD04, a genetically targeted therapeutic agent for the treatment of alcohol use disorder (“AUD”).

The company's most significant milestone during the period was the announcement of an update to its regulatory strategy for AD04. The optimized genetic panel would enable the company to target specific modulators of the serotonin 3 receptor A & B subunit genotypes that outperformed others. The data from ONWARD Phase 3 clinical trial showed that AD04 was successful in achieving a statistically significant mean reduction in heavy drinking days among the pre-specified group of “heavy drinkers” (defined as those drinking less than 10 drinks per drinking day).

Additionally, the market research conducted suggests that unit pricing for AD04 could be significantly higher than previous assumptions. Moreover, the company has scheduled meetings with two European country-level regulatory authorities and requested to meet three European country-level regulatory authorities to discuss its clinical program. The company has also confirmed its intentions to conduct a type C meeting with the U.S. Food and Drug Administration in Q2 2023 to discuss its clinical program in the U.S.

However, the company's cash and cash equivalents at the end of the period are projected not to be sufficient to fund operations for the next twelve months. A failure to raise additional funds or enter into other arrangements as and when needed could have a negative impact on the company's financial condition and its ability to develop AD04.

PART 2: Forward Looking Analysis

The company's focus on addiction and related disorders offers growth potential as it seeks to create the world's leading addiction-focused pharmaceutical company. The company's strategy is to explore opportunities to expand its portfolio internally and through acquisitions, which presents an opportunity for future growth.

The expansion of the optimized genetic panel used in the development of AD04 can lead to better results from the clinical trial. The refinement of the genetic panel indicates the company's commitment to researching and developing more effective treatments for AUD.

The outcome of the type C meeting with the U.S. Food and Drug Administration is crucial. The meeting will enable the company to discuss its clinical program in the U.S., which could potentially lead to regulatory acceptance and the eventual commercialization of AD04. The company's plan to meet with two European country-level regulatory authorities and request meetings with three European country-level regulatory authorities also indicates its commitment to regulatory compliance and successful commercialization in Europe.

Furthermore, the market research conducted suggests that unit pricing for AD04 could be significantly higher than previous assumptions. This pricing point, coupled with the identification of the genetic sub-group that AD04 works best on, could lead to significant revenue from product sales, which could fund the company's operations and increase investor's confidence in the company.

Overall, the company's dedication to researching and developing more effective treatments for AUD and related disorders, plans to meet with regulatory authorities, and market research indicate the potential for significant growth in the long-term. However, it is crucial for the company to secure additional funds or enter into profitable arrangements to fund its operations and take advantage of growth opportunities.

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Adial's AD04 Shows Promise in Treating Alcohol Use Disorder

Form 8-K - Current report - Item 1.01 Item 7.01 Item 9.01

OPTION EXERCISE AGREEMENT, DATED MAY 8, 2023, BY AND BETWEEN ADOVATE LLC AND ADI

PRESS RELEASE ISSUED BY ADIAL PHARMACEUTICALS, INC

Form 8-K - Current report - Item 5.07 Item 9.01

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has reported its financial results for the fiscal year 2022 ending December 31, 2022. The company has ended the 2022 fiscal year with $4 million in cash and cash equivalents, positioning itself in a much stronger financial position, while focusing on strategic partnership opportunities to further the clinical development and commercialization of AD04. Moreover, Adial Pharmaceuticals has secured meetings with U.S. and European regulatory agencies that are intended to provide a clearer understanding of a path forward to obtain regulatory approval. The company is encouraged by its progress, and it plans to provide further updates.

The company has successfully made significant advancements throughout the year, including announcing topline data from ONWARD, its pivotal phase 3 clinical trial evaluating the efficacy, safety, and tolerability of AD04 in patients with Alcohol Use Disorder (AUD). ONWARD results showed that AD04 achieved a statistically significant reduction of heavy drinking days in the "heavy drinkers" subgroup of patients. Adial Pharmaceuticals has identified two specific genotypes that outperformed the others, which provides the company with a high level of confidence in its ability to pursue and obtain regulatory approval in the United States and Europe. 

Adial Pharmaceuticals is also developing adenosine analogs for the treatment of pain and other disorders, and it has recently engaged the Keswick Group, LLC, a biotech strategic commercial, and business development advisory firm, to support advancement of the company's partnering activities. The company has entered into an option agreement for the sale of the assets of Purnovate, Inc., a wholly-owned subsidiary of Adial, to Adovate, LLC. The acquisition agreement will enable Adial Pharmaceuticals to receive up to approximately $11 million in development and approval milestones for each compound, as well as a total of $50 million in additional commercial milestones, for a total consideration of up to $83 million with potential milestone payments on additional compounds. However, investors should note that forward-looking statements 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.

PRESS RELEASE ISSUED BY ADIAL PHARMACEUTICALS, INC., DATED MARCH 30, 2023

Announcement: ADIL 8-K Special Filing

Announcement: ADIL 8-K Special Filing

$ADIL Reports Positive Q1 Financial Results and Advances Regulatory Strategy and Partnership Discussions

$ADIL Reports Positive Q1 Financial Results and Advances Regulatory Strategy and Partnership Discussions

Adial's AD04 Shows Promise in Treating Alcohol Use Disorder

Adial's AD04 Shows Promise in Treating Alcohol Use Disorder

Announcement: ADIL 8-K Special Filing

Announcement: ADIL 8-K Special Filing

Announcement: ADIL 8-K Special Filing

Announcement: ADIL 8-K Special Filing

$ADIL Reports Strong Financial Position and Advancements in Clinical Trials

$ADIL Reports Strong Financial Position and Advancements in Clinical Trials