Adial Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q3 2025 results and a business update on Nov 14, 2025. Key regulatory progress included a successful End of Phase 2 (EOP2) meeting with FDA providing guidance on an adaptive Phase 3 design, and confirmation that the company's cheek swab Genomind test is a Non-Significant Risk (NSR) for use in Phase 3. The company targets biomarker-positive (AG+) AUD patients, citing an AG+ prevalence of ~14%. Intellectual property work includes a provisional patent update filed July 9, 2025, expected to protect core assets through 2045. Financially, cash was $4.6M at Sept 30, 2025 (down from $5.9M), the company expects funding into Q2 2026, R&D expense fell ~50% YoY, and net loss was $1.8M for Q3 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) ha riportato i risultati del Q3 2025 e un aggiornamento sull’attività il 14 novembre 2025. I progressi normativi chiave hanno incluso un incontro End of Phase 2 (EOP2) riuscito con la FDA, che ha fornito indicazioni su un design adattivo della fase 3, e la conferma che il test Genomind prelievo guance è un NSR (Non-Significant Risk) per l’uso in fase 3. L’azienda punta a pazienti AUD biomarker-positivi (AG+), citando una prevalenza AG+ di circa il 14%. Il lavoro di proprietà intellettuale prevede un aggiornamento di brevetto provvisorio presentato il 9 luglio 2025, che dovrebbe proteggere gli asset chiave fino al 2045. Dal punto di vista finanziario, la liquidità ammontava a 4,6 milioni di dollari al 30 settembre 2025 (in calo rispetto ai 5,9 milioni), l’azienda prevede finanziamenti fino al Q2 2026, le spese di R&D sono scese di circa 50% su base annua e la perdita netta è stata di 1,8 milioni di dollari nel Q3 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) informó resultados del 3T 2025 y una actualización de negocio el 14 de noviembre de 2025. Los avances regulatorios clave incluyeron una exitosa reunión End of Phase 2 (EOP2) con la FDA, que proporcionó direcciones sobre un diseño adaptativo de la fase 3, y la confirmación de que la prueba Genomind con hisopo de mejilla es un NSR (riesgo no significativo) para uso en la fase 3. La empresa apunta a pacientes con AUD biomarcador-positivos (AG+), citando una prevalencia AG+ de aproximadamente 14%. El trabajo de propiedad intelectual incluye una actualización de patente provisional presentada el 9 de julio de 2025, que se espera proteja los activos principales hasta 2045. Financieramente, el efectivo fue de 4,6 millones de dólares al 30 de septiembre de 2025 (bajo los 5,9 millones), la empresa espera financiamiento hasta el Q2 de 2026, los gastos de I+D cayeron aproximadamente un 50% interanual y la pérdida neta fue de 1,8 millones de dólares para el 3T 2025.
Adial Pharmaceuticals (NASDAQ: ADIL)는 2025년 11월 14일 2025년 3분기 실적 및 사업 업데이트를 발표했습니다. 주요 규제 진행 사항으로는 FDA와의 End of Phase 2(EOP2) 미팅 성공이 포함되어 적응형 3상 설계에 대한 가이던스를 제공했고, 볼점 검체 Genomind 테스트가 3상에서 NSR(비위험)로 사용될 수 있음을 확인했습니다. 회사는 바이오마커 양성(GA+) AUD 환자에 초점을 맞추며 GA+ 유병률을 약 14%로 인용합니다. 지식재산권 작업으로는 2025년 7월 9일 제출된 잠정 특허 업데이트가 있으며, 이는 핵심 자산을 2045년까지 보호할 것으로 예상됩니다. 재무적으로 현금은 2025년 9월 30일 기준 460만 달러였고(이전 590만 달러 대비 감소), 회사는 2026년 2분기까지 자금을 조달할 것으로 기대하며, R&D 비용은 전년 대비 약 50% 감소했고 3분기 순손실은 180만 달러였습니다.
Adial Pharmaceuticals (NASDAQ : ADIL) a publié les résultats du T3 2025 et une mise à jour commerciale le 14 novembre 2025. Les progrès réglementaires clés incluaient une réunion End of Phase 2 (EOP2) réussie avec la FDA, qui a fourni des orientations sur une conception adaptative de la phase 3, et la confirmation que le test Genomind prélevé sur les joues est un NSR (Non-Significant Risk) pour une utilisation en phase 3. L’entreprise vise des patients AUD positifs pour les biomarqueurs (AG+), citant une prévalence AG+ d’environ 14%. Le travail sur la propriété intellectuelle comprend une mise à jour de brevet provisoire déposée le 9 juillet 2025, destinée à protéger les actifs clés jusqu’en 2045. Sur le plan financier, la trésorerie était de 4,6 millions de dollars au 30 septembre 2025 (en baisse par rapport à 5,9 millions), l’entreprise prévoit un financement jusqu’au Q2 2026, les dépenses de R&D ayant chuté d’environ 50% d’une année sur l’autre, et la perte nette était de 1,8 million de dollars pour le T3 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) meldete am 14. November 2025 die Ergebnisse des dritten Quartals 2025 und ein Update zum Geschäft. Wichtige regulatorische Fortschritte umfassen ein erfolgreiches End-of-Phase-2 (EOP2) Meeting mit der FDA, das Anleitungen für ein adaptives Design der Phase 3 lieferte, und die Bestätigung, dass der Genomind-Test mit Wangenabstrich ein NSR (Non-Significant Risk) für den Einsatz in Phase 3 ist. Das Unternehmen zielt auf biomarker-positive (AG+) AUD-Patienten ab und verweist auf eine AG+-Prävalenz von ca. 14%. Im Bereich geistiges Eigentum gibt es ein Update zu einer vorläufigen Patentanmeldung vom 9. Juli 2025, das voraussichtlich die Kernvermögenswerte bis 2045 schützt. Finanziell betrug der Cash-Bestand zum 30. September 2025 4,6 Mio. USD (gegenüber 5,9 Mio. USD), das Unternehmen rechnet mit Finanzierung bis zum Q2 2026, die F&E-Ausgaben sanken gegenüber dem Vorjahr um ca. 50%, und der Nettogewinn betrug im Q3 2025 −1,8 Mio. USD.
Adial Pharmaceuticals (NASDAQ: ADIL) أعلنت عن نتائج الربع الثالث من عام 2025 وتحديث الأعمال في 14 نوفمبر 2025. شملت التقدمات التنظيمية الرئيسية اجتماع End of Phase 2 (EOP2) ناجح مع إدارة الغذاء والدواء الأمريكية (FDA) قدم توجيهات حول تصميم مرن للمرحلة 3، وتأكيد أن اختبار Genomind المسحة الخدّ هو NSR (خطر غير مهم) للاستخدام في المرحلة 3. تستهدف الشركة مرضى AUD الإيجابيين بالعلامات الحيوية (AG+)، مشيرة إلى انتشار AG+ بنحو 14%. تتضمن أعمال الملكية الفكرية تحديث براءة اختراع احتياطي مقدّم في 9 يوليو 2025، ومن المتوقع أن يحمي الأصول الأساسية حتى عام 2045. ماليًا، كان النقد المتوافر 4.6 مليون دولار في 30 سبتمبر 2025 (انخفاض من 5.9 مليون)، وتتوقع الشركة تمويلاً حتى الربع الثاني من 2026، وانخفضت نفقات البحث والتطوير بحوالي 50% على أساس سنوي، وكانت الخسارة الصافية 1.8 مليون دولار للربع الثالث من 2025.
- FDA EOP2 meeting provided Phase 3 adaptive design guidance
- Genomind cheek swab test confirmed as NSR for Phase 3
- R&D expenses fell approximately 50% YoY in Q3 2025
- Provisional patent update filed July 9, 2025 protecting assets to 2045
- Cash declined to $4.6M as of Sept 30, 2025
- Cash decreased from $5.9M on June 30, 2025
- Company's cash expected to fund operations only into Q2 2026
- Net loss of $1.8M for Q3 2025
Insights
FDA End-of-Phase-2 guidance and validated companion test advance registrational plans, but cash runway remains limited to mid-2026.
Adial secured substantive, actionable guidance from the FDA on an adaptive Phase 3 design for AD04, including target population, endpoints, dosing, and separate biomarker strata. The company also completed analytical validation of a cheek‑swab companion test with Genomind and received FDA confirmation that use of the test in the Phase 3 study is a Non‑Significant Risk (NSR) device, removing the need for an IDE and simplifying trial logistics.
The near‑term development picture now rests on three dependencies and risks: executing the adaptive Phase 3 protocol reflecting the FDA recommendations, enrolling the biomarker‑positive subgroup (AG+ ~
Watchables over a 6–18 month horizon include: (1) finalization and publicization of the Phase 3 protocol and timeline, (2) any announced strategic partnerships or financing to extend runway, and (3) operational milestones tied to patient identification using the Genomind test. The combination of clear FDA input and an NSR determination materially derisks trial design, while the limited cash runway materially raises execution risk absent near‑term funding.
GLEN ALLEN, Va., Nov. 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 third quarter of 2025.
Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We continue to achieve meaningful milestones on our path toward U.S. Food and Drug Administration (FDA) approval and eventual commercialization of AD04, our lead investigational drug, a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). A key highlight of our recent progress was the successful End of Phase 2 (EOP2) meeting with the FDA, where we received valuable guidance on critical elements of our planned adaptive Phase 3 study design — including the target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and validation of both biomarker-positive and biomarker-negative groups.”
“We are now implementing the FDA’s recommendations based on this meeting, positioning us to advance confidently toward registrational Phase 3 development. The AD04 program aims to deliver targeted and commercially focused success following approval, specifically for patients who are biomarker-positive for AG+, a subset of the AUD population identified through our proprietary genetic test. The AG+ biomarker is found in approximately
“We are also encouraged by recent U.S. Senate support for expanding clinical trial endpoints beyond abstinence in evaluating treatments for Alcohol and Substance Use Disorders. The bipartisan Appropriations Committee’s recommendation for the FDA and the National Institute on Drug Abuse (NIDA) to consider additional measures, such as reduced cravings, decreased use, and lowered disorder severity, strongly reinforces our therapeutic approach and patient-centered philosophy. Our AD04 program has always focused on reducing alcohol consumption and cravings rather than enforcing an all-or-nothing abstinence model, and it is encouraging to see legislative recognition of the need for more realistic and compassionate treatment outcomes. This forward-looking perspective aligns with the core of our development strategy and further validates our belief that AD04 is uniquely positioned to benefit from this evolving regulatory environment.”
“To further support these efforts, we have partnered with Genomind to develop our precision medicine testing solution. Together, we have completed the analytical validation of a cheek swab collection method to identify eligible patients — a critical step for both clinical trial implementation and future commercial use. This achievement represents a major milestone in our journey toward FDA approval and lays the groundwork for a commercial companion diagnostic test that can be easily performed in a physician’s office or at home. During our recent EOP2 meeting, the FDA also confirmed that use of this test in the Phase 3 study represents a Non-Significant Risk (NSR), meaning an Investigational Device Exemption (IDE) application is not required.”
“Collectively, these accomplishments provide strong momentum and confidence as we prepare for our Phase 3 program. They are also driving strategic partnership discussions, which we expect to accelerate as we continue to reach key milestones. We remain committed to disciplined execution and believe AD04 has the potential to become the first genetically targeted therapy approved for AUD — addressing a major unmet medical need with significant commercial opportunity.”
Other Developments
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.
Third Quarter 2025 Financial Results
- Cash and cash equivalents were
$4.6 million as of September 30, 2025, compared to$5.9 million as of June 30, 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
$511 thousand (50% ) during the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The key driver of the decrease was lower clinical activity in the three months ended September 30, 2025 as compared to the same period in 2024. - General and administrative expenses increased by approximately
$63 thousand (5% ) during the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The increase was mainly due to the timing of our annual meeting, which occurred in the third quarter in 2025 vs. the fourth quarter in 2024. - Net Loss was
$1.8 million for the three months ended September 30, 2025, compared to a net loss of$2.2 million for the three months ended September 30, 2024. The decrease in net loss was primarily driven by lower R&D spending.
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 FDA approval and eventual commercialization of AD04, implementing the FDA’s recommendations based on the EOP2 meeting, being positioned to advance confidently toward registrational Phase 3 development, the AD04 program delivering targeted and commercially focused success following approval specifically for patients who are biomarker-positive for AG+, AD04 being uniquely positioned to benefit from the evolving regulatory environment in evaluating treatments for Alcohol and Substance Use Disorders, laying the groundwork for a commercial companion diagnostic test that can be easily performed in a physician’s office or at home, accelerating strategic partnership discussions as the Company continues to reach key milestones, remaining committed to disciplined execution, AD04 having the potential to become the first genetically targeted therapy approved for AUD addressing a major unmet medical need with significant commercial opportunity, protecting Adial’s core assets out to at least 2045 with the patent for AD04, once granted, 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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