Adial Pharmaceuticals Receives Milestone Payment from Adovate Following Initiation of Phase 1 Study

Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL) has received a six-figure milestone payment from Adovate following the initiation of a Phase 1 clinical trial for ADO-5030, a novel asthma therapy. The payment comes after Adovate's acquisition of Purnovate, Adial's former subsidiary. The Phase 1 study is evaluating the safety and pharmacokinetics of their adenosine receptor antagonist in healthy volunteers.

Under the agreement, Adial is eligible to receive up to $83 million in milestone payments for the first three compounds, including over $50 million in commercial milestones and $11 million in development milestones per compound. Additionally, Adial maintains low single-digit royalties on net sales and a 10%+ equity stake in Adovate, allowing participation in future upside potential.

[ "Receipt of six-figure milestone payment providing non-dilutive capital", "Potential for up to $83 million in milestone payments for first three compounds", "Retained 10%+ equity stake in Adovate", "Additional revenue potential through low single-digit royalties on future net sales", "Strategic monetization of Purnovate assets while maintaining upside exposure" ]

Positive

• None.

Negative

• Dependent on Adovate's success in clinical development and commercialization
• Early-stage Phase 1 trial with significant development risks ahead

Insights

Pharmaceutical Business Development Expert

Adial received milestone payment from Adovate and maintains upside potential through milestone structure worth up to $83M plus equity and royalties.

This milestone payment represents positive validation for Adial's business development strategy. The company has successfully structured a deal that provides six-figure non-dilutive capital while maintaining significant upside through milestone payments, royalties, and equity ownership.

The deal structure is particularly sophisticated, with Adial eligible to receive over $50 million in commercial milestone payments, an additional $11 million in development and approval milestone payments per compound, and low single-digit royalties on net sales. Importantly, this arrangement covers the first three compounds alone, with total potential consideration reaching $83 million if all milestones are achieved.

The 10%+ equity retention in Adovate gives Adial shareholders meaningful exposure to the asthma program's future success without requiring additional capital investment. This transaction effectively monetizes the Purnovate assets while allowing Adial to focus its resources on its core AD04 program.

The milestone was triggered by the initiation of a Phase 1 Single Ascending Dose study evaluating ADO-5030's safety, tolerability, and pharmacokinetics in healthy volunteers. While early-stage, the target market (asthma) represents a multi-billion dollar opportunity with substantial unmet needs, providing significant commercial potential.

For investors, this development demonstrates management's ability to extract value from non-core assets while maintaining focus on their primary clinical programs. The non-dilutive cash infusion strengthens Adial's financial position in the near term, while the milestone structure creates potential value inflection points tied to Adovate's clinical progress.

Milestone Achieved as Adovate Initiates First-in-Human Study for Novel Asthma Therapy Targeting Underserved, Multi-Billion Dollar Market

Glen Allen, Va., May 13, 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 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. The ongoing Phase 1 study is a Single Ascending Dose (SAD) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of Adovate’s novel adenosine receptor antagonist in healthy volunteers. The compound is being developed as a potential first-line therapy for asthma, a large and underserved global market with substantial unmet medical needs, with a differentiated mechanism of action and the potential to shift the treatment paradigm for asthma patients globally.

Cary Claiborne, CEO of Adial Pharmaceuticals, said “This milestone highlights the value of our strategic decision to monetize the Purnovate assets while retaining meaningful upside. The structure of the deal provides non-dilutive capital and a strong equity position, allowing us to focus our resources on advancing AD04 while continuing to benefit from the progress Adovate is making in asthma and other indications.”

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.

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 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 Adovate’s development of the ADO-5030 as a first-line therapy for asthma, the potential to shift the treatment paradigm for asthma patients globally, Adial advancing AD04 while continuing to benefit from the progress Adovate is making in asthma and other indications, receiving 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, positioning Adial to participate in the long-term upside as Adovate’s asthma candidate advances through clinical development and toward potential commercialization 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, Adovate’s ability to develop ADO-5030 as a first-line therapy for asthma, Adovate’s ability to achieve the milestones under the terms of the agreement with us, Adovate’s ability to advance its asthma candidate through clinical development and toward potential commercialization; 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: ADIL@crescendo-ir.com

FAQ

What milestone payment did ADIL receive from Adovate in May 2025?

Adial Pharmaceuticals received a six-figure milestone payment following the initiation of a Phase 1 clinical trial for ADO-5030, Adovate's asthma therapy.

What is the total potential milestone payment value for ADIL from the Adovate agreement?

Adial can receive up to $83 million in milestone payments for the first three compounds, including over $50 million in commercial milestones and $11 million in development milestones per compound.

What equity stake does ADIL retain in Adovate?

Adial Pharmaceuticals maintains over 10% equity stake in Adovate.

What royalties will ADIL receive from Adovate's product sales?

Adial is entitled to low single-digit royalties on net sales if the program reaches commercialization.

What is the current stage of Adovate's asthma therapy development?

Adovate has initiated a Phase 1 Single Ascending Dose (SAD) clinical trial to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers.