Adial Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q2 2025 financial results and provided significant updates on its AD04 drug development program for Alcohol Use Disorder (AUD). The company successfully completed its End of Phase 2 FDA meeting, receiving crucial input for its upcoming Phase 3 trial design. Cash position strengthened to $5.9 million as of June 30, 2025, up from $2.4 million in Q1, supported by a $3.0 million public offering.
Key developments include securing U.S. manufacturing partnerships with Thermo Fisher Scientific and Cambrex, regaining Nasdaq compliance, and filing an updated provisional patent expected to protect core assets until 2045. The company reported a reduced net loss of $2.0 million compared to $2.5 million in Q2 2024, with decreased R&D expenses by 28% and G&A expenses by 10%.
Adial Pharmaceuticals (NASDAQ: ADIL) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti rilevanti sul programma di sviluppo del farmaco AD04 per il disturbo da uso di alcol (AUD). L'azienda ha completato con successo l'incontro End of Phase 2 con la FDA, ottenendo indicazioni fondamentali per la progettazione del prossimo studio di Fase 3. La posizione di cassa si è rafforzata a 5,9 milioni di dollari al 30 giugno 2025, rispetto ai 2,4 milioni del primo trimestre, sostenuta da un'offerta pubblica da 3,0 milioni di dollari.
Tra gli sviluppi principali figurano la stipula di partnership di produzione negli USA con Thermo Fisher Scientific e Cambrex, il ripristino della conformità al Nasdaq e il deposito di un brevetto provvisorio aggiornato che dovrebbe tutelare gli asset principali fino al 2045. L'azienda ha riportato una perdita netta ridotta a 2,0 milioni di dollari rispetto ai 2,5 milioni del Q2 2024, con spese di R&S in calo del 28% e spese G&A diminuite del 10%.
Adial Pharmaceuticals (NASDAQ: ADIL) informó los resultados financieros del segundo trimestre de 2025 y ofreció avances significativos en su programa de desarrollo del fármaco AD04 para el trastorno por consumo de alcohol (AUD). La compañía completó con éxito la reunión End of Phase 2 con la FDA, recibiendo orientaciones clave para el diseño del próximo ensayo de Fase 3. La posición de efectivo se fortaleció hasta 5,9 millones de dólares al 30 de junio de 2025, frente a 2,4 millones en el primer trimestre, respaldada por una oferta pública de 3,0 millones de dólares.
Entre los hitos principales están la aseguración de alianzas de fabricación en EE. UU. con Thermo Fisher Scientific y Cambrex, la recuperación del cumplimiento con Nasdaq y la presentación de una solicitud provisional de patente actualizada que se espera proteja los activos clave hasta 2045. La compañía informó una pérdida neta reducida de 2,0 millones de dólares frente a 2,5 millones en el Q2 de 2024, con gastos de I+D disminuidos en un 28% y gastos G&A en un 10%.
Adial Pharmaceuticals (NASDAQ: ADIL)는 2025년 2분기 재무실적을 발표하고 알코올 사용 장애(AUD) 치료제 AD04 개발 프로그램에 대한 주요 업데이트를 공개했습니다. 회사는 FDA와의 End of Phase 2 미팅을 성공적으로 마쳐 향후 3상 시험 설계에 대한 중요한 의견을 받았습니다. 현금 보유액은 2025년 6월 30일 기준 590만 달러로 강화되었으며, 이는 1분기 240만 달러에서 증가한 수치로 300만 달러의 공모 자금이 이를 뒷받침했습니다.
주요 발전 사항으로는 Thermo Fisher Scientific 및 Cambrex와의 미국 내 제조 파트너십 확보, 나스닥 규정 준수 회복, 그리고 핵심 자산을 2045년까지 보호할 것으로 예상되는 갱신된 임시 특허 출원이 포함됩니다. 회사는 순손실이 200만 달러로 축소되었음을 보고했으며(2024년 2분기 250만 달러 대비), 연구개발비는 28% 감소하고 총관리비는 10% 감소했습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a publié ses résultats financiers du deuxième trimestre 2025 et a communiqué des mises à jour importantes sur son programme de développement du médicament AD04 pour le trouble lié à l'usage d'alcool (AUD). La société a mené à bien la réunion End of Phase 2 avec la FDA, obtenant des recommandations clés pour la conception de l'essai de phase 3 à venir. La trésorerie s'est renforcée à 5,9 millions de dollars au 30 juin 2025, contre 2,4 millions au premier trimestre, soutenue par une offre publique de 3,0 millions de dollars.
Parmi les avancées majeures figurent la conclusion de partenariats de fabrication aux États-Unis avec Thermo Fisher Scientific et Cambrex, le rétablissement de la conformité au Nasdaq et le dépôt d'une demande de brevet provisoire mise à jour, qui devrait protéger les actifs clés jusqu'en 2045. La société a déclaré une perte nette réduite à 2,0 millions de dollars contre 2,5 millions au T2 2024, avec des dépenses R&D en baisse de 28% et des frais G&A en diminution de 10%.
Adial Pharmaceuticals (NASDAQ: ADIL) veröffentlichte die Finanzergebnisse für das 2. Quartal 2025 und gab wesentliche Aktualisierungen zu seinem AD04-Entwicklungsprogramm für Alkoholgebrauchsstörung (AUD) bekannt. Das Unternehmen hat das End-of-Phase-2-Meeting mit der FDA erfolgreich abgeschlossen und dabei wichtige Hinweise für die Planung der bevorstehenden Phase-3-Studie erhalten. Die Barbestände erhöhten sich zum 30. Juni 2025 auf 5,9 Millionen US-Dollar, nach 2,4 Millionen im ersten Quartal, gestützt durch ein öffentliches Platzierungsvolumen von 3,0 Millionen US-Dollar.
Zu den wichtigsten Entwicklungen zählen die Sicherung von Produktionspartnerschaften in den USA mit Thermo Fisher Scientific und Cambrex, die Wiederherstellung der Nasdaq-Compliance sowie die Einreichung einer aktualisierten vorläufigen Patentanmeldung, die die Kernwerte voraussichtlich bis 2045 schützen wird. Das Unternehmen meldete einen reduzierten Nettoverlust von 2,0 Millionen US-Dollar gegenüber 2,5 Millionen im Q2 2024, bei einem Rückgang der F&E-Ausgaben um 28% und der Verwaltungs- und Vertriebskosten um 10%.
- Successful completion of FDA End of Phase 2 meeting with agreement on key Phase 3 trial protocol elements
- Cash position increased to $5.9 million from $2.4 million quarter-over-quarter
- Secured U.S. manufacturing agreements with Thermo Fisher Scientific and Cambrex
- Regained Nasdaq compliance with stockholders' equity requirement
- Net loss reduced to $2.0 million from $2.5 million year-over-year
- Filed updated provisional patent potentially extending protection until 2045
- Required $3.0 million dilutive public offering with warrant issuance
- Current cash runway only extends into Q2 2026
- Significant share dilution with 11.1 million new shares and additional warrants issued
Insights
Adial shows promising regulatory progress for its AUD treatment but continues to burn cash despite reduced expenses.
Adial Pharmaceuticals has reached a critical regulatory milestone with the completion of its End of Phase 2 meeting with the FDA for AD04, its genetically-targeted treatment for Alcohol Use Disorder (AUD). The FDA's input on trial design elements—including patient population selection, endpoints, and biomarker stratification—represents significant progress toward initiating Phase 3 trials.
The company has strengthened its manufacturing position by securing partnerships with Thermo Fisher Scientific and Cambrex for drug product and substance supply, reducing supply chain risks and enhancing their Chemistry, Manufacturing, and Controls (CMC) position for future New Drug Application submission.
On the intellectual property front, Adial has filed an update to its provisional patent application for AD04, which could extend protection until at least 2045 if granted, significantly enhancing the long-term commercial potential of their lead asset.
Financially, Adial has improved its position with a
While Adial projects that current funds will support operations into Q2 2026, the company remains in a cash-burning phase typical of clinical-stage biotechs. The recent Nasdaq compliance achievement (regaining the
The strategic positioning of AD04 as potentially the first genetically targeted therapy for AUD—a condition with significant unmet need—could make Adial an attractive partnership candidate as they advance toward Phase 3, potentially creating value inflection points in the near to medium term.
Adial secures FDA alignment on Phase 3 design and strengthens financial position, but still faces significant execution challenges ahead.
Adial's successful End of Phase 2 meeting with the FDA represents a significant de-risking event, with the agency providing favorable feedback on the Phase 3 trial design for AD04. The agreement on key elements including patient population selection, endpoints, and the incorporation of genetic biomarkers for patient stratification suggests a well-defined regulatory pathway. Particularly noteworthy is the FDA's apparent receptiveness to the company's adaptive enrichment strategies, which could potentially optimize trial efficiency.
The collaboration with Cytel for precision medicine approaches adds scientific credibility to Adial's development strategy. By leveraging machine learning and simulation modeling to identify genetic markers associated with treatment response, the company is pursuing a targeted approach that could improve efficacy signals and reduce required sample sizes—a critical consideration for a small biotech with limited resources.
On the financial front, Adial has strengthened its position through a
The regaining of Nasdaq compliance removes an immediate threat to the company's listing status, but the continued issuance of shares and warrants (11.1 million shares plus substantial warrants in the recent offering) at relatively low prices (
The patent application update potentially extending protection to 2045 represents a valuable long-term asset, but Adial still faces substantial execution risks in translating its promising approach into commercial success in the challenging AUD market.
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
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
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 (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 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: ADIL@crescendo-ir.com
FAQ
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