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Adial Pharmaceuticals Receives Notice of Allowance for U.S. Patent Covering Expanded Genotype Combinations Identified Using the Company’s Genetic Diagnostic for Addiction Treatment

Key Takeaway: Adial Pharmaceuticals announced a Notice of Allowance for a new patent that expands its intellectual property for AD04, a drug targeting alcohol use disorder. This patent covers additional genotype combinations identified through a proprietary genetic diagnostic tool, enhancing the precision medicine approach. The CEO emphasized the importance of this milestone in advancing their commitment to innovative addiction treatments.
Price reaction · baseline $25.75 (2024-10-16 close) · hit pre-market · clean, no other ADIL news in the window
day 0 close
-5.8%
day 1
-1.9%
day 3 · peak
+13.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • Notice of Allowance for a new patent enhances intellectual property.
  • AD04 shows promising results in reducing heavy drinking.
  • Focus on genetically-targeted treatments could improve addiction therapies.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+9%
120-day peak, hindsight
Typical move
9.1%
average across 4 past catalysts
Cash runway
~6 mo
High dilution risk
Lead asset
AD04
Phase 3 · Alcohol Use Disorder

Full Press Release Details

GLEN ALLEN, Va., Oct. 17, 2024 — 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 announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a new patent.
The patent, once issued, will expand Adial’s intellectual property protection around its lead investigational drug, AD04, which is designed to treat alcohol use disorder (AUD). The new patent covers additional genotype combinations identified through the Company’s proprietary genetic diagnostic tool, further enhancing the precision medicine approach of AD04.
“This Notice of Allowance represents an important milestone for Adial as we continue to broaden our patent estate,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Securing protection for these additional genotype combinations provides us with greater flexibility as we advance AD04 and reinforces our commitment to delivering innovative, genetically-targeted treatments for addiction. This patent notification is a further testament to our commitment to harnessing cutting-edge science for the betterment of countless lives affected by addiction. By understanding the genetic factors that play a role in addiction, we believe we can pave the way for treatments that are more effective and have fewer side effects.”
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 (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change in 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 advancing AD04 and delivering innovative, genetically-targeted treatments for addiction, harnessing cutting-edge science for the betterment of countless lives affected by addiction, paving the way for treatments that are more effective and have fewer side effects by understanding the genetic factors that play a role in addiction 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.

Frequently Asked Questions

What is the significance of the Notice of Allowance?

The Notice of Allowance signifies that Adial has received approval for a new patent, enhancing its intellectual property for AD04.

What does the new patent cover?

The new patent covers additional genotype combinations identified through Adial's genetic diagnostic tool.

What is AD04 designed to treat?

AD04 is designed to treat alcohol use disorder (AUD) and may also address other addictive disorders.

What were the results of the ONWARD trial?

The ONWARD trial showed promising results in reducing heavy drinking among patients with specific genotypes.

Last updated: Oct 17, 2024