Adial Pharmaceuticals Reports 2024 Fiscal Year Financial Results and Provides Business Update
Adial Pharmaceuticals (NASDAQ: ADIL) reported its fiscal year 2024 results and key developments in its AD04 program for Alcohol Use Disorder (AUD) treatment. The company successfully completed the AD04-103 pharmacokinetics study, receiving FDA confirmation for its 505(b)(2) bridging strategy and advancing towards Phase 3 trials in 2025.
Financial highlights include:
- Cash position of $3.8 million as of December 31, 2024 (up from $2.8M in 2023)
- Net loss increased to $13.2 million (compared to $5.1M in 2023)
- R&D expenses rose by $1.9 million (155%)
- G&A expenses decreased by $491,000 (9%)
The company strengthened its IP portfolio with three new US patents covering genetic-based approaches for treating AUD and other drug dependencies. Adial partnered with Boudicca Dx for companion diagnostic test development and appointed Vinay Shah as CFO.
Adial Pharmaceuticals (NASDAQ: ADIL) ha riportato i risultati dell'anno fiscale 2024 e gli sviluppi chiave del suo programma AD04 per il trattamento del Disturbo da Uso di Alcol (AUD). L'azienda ha completato con successo lo studio di farmacocinetica AD04-103, ricevendo la conferma della FDA per la sua strategia di bridging 505(b)(2) e avanzando verso le sperimentazioni di Fase 3 nel 2025.
I punti salienti finanziari includono:
- Posizione di cassa di $3,8 milioni al 31 dicembre 2024 (in aumento rispetto ai $2,8 milioni del 2023)
- Perdita netta aumentata a $13,2 milioni (rispetto ai $5,1 milioni del 2023)
- Le spese per R&S sono aumentate di $1,9 milioni (155%)
- Le spese generali e amministrative sono diminuite di $491.000 (9%)
L'azienda ha rafforzato il suo portafoglio di proprietà intellettuale con tre nuovi brevetti statunitensi che coprono approcci basati sulla genetica per il trattamento dell'AUD e di altre dipendenze da sostanze. Adial ha collaborato con Boudicca Dx per lo sviluppo di test diagnostici complementari e ha nominato Vinay Shah come CFO.
Adial Pharmaceuticals (NASDAQ: ADIL) informó sobre los resultados de su año fiscal 2024 y los desarrollos clave en su programa AD04 para el tratamiento del Trastorno por Uso de Alcohol (AUD). La compañía completó con éxito el estudio de farmacocinética AD04-103, recibiendo la confirmación de la FDA para su estrategia de puente 505(b)(2) y avanzando hacia ensayos de Fase 3 en 2025.
Los aspectos financieros destacados incluyen:
- Posición de efectivo de $3.8 millones al 31 de diciembre de 2024 (aumento desde $2.8M en 2023)
- Pérdida neta aumentada a $13.2 millones (en comparación con $5.1M en 2023)
- Los gastos de I+D aumentaron en $1.9 millones (155%)
- Los gastos generales y administrativos disminuyeron en $491,000 (9%)
La compañía fortaleció su cartera de propiedad intelectual con tres nuevas patentes en EE. UU. que cubren enfoques basados en genética para el tratamiento del AUD y otras dependencias de sustancias. Adial se asoció con Boudicca Dx para el desarrollo de pruebas diagnósticas complementarias y nombró a Vinay Shah como CFO.
Adial Pharmaceuticals (NASDAQ: ADIL)는 2024 회계연도 결과와 알코올 사용 장애(AUD) 치료를 위한 AD04 프로그램의 주요 개발 사항을 보고했습니다. 이 회사는 AD04-103 약리학 연구를 성공적으로 완료하고, 505(b)(2) 브리징 전략에 대한 FDA의 승인을 받았으며, 2025년 3상 시험으로 나아가고 있습니다.
재무 하이라이트는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 $3.8 백만 (2023년의 $2.8M에서 증가)
- 순손실이 $13.2 백만으로 증가 (2023년의 $5.1M과 비교)
- 연구개발(R&D) 비용이 $1.9 백만 증가 (155%)
- 일반관리(G&A) 비용이 $491,000 감소 (9%)
회사는 AUD 및 기타 약물 의존증 치료를 위한 유전자 기반 접근 방식을 다루는 미국 내 3개의 새로운 특허로 IP 포트폴리오를 강화했습니다. Adial은 Boudicca Dx와 협력하여 동반 진단 테스트 개발을 진행하고 Vinay Shah를 CFO로 임명했습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé ses résultats pour l'exercice fiscal 2024 et les principales avancées de son programme AD04 pour le traitement du Trouble de l'Usage de l'Alcool (AUD). L'entreprise a réussi à compléter l'étude de pharmacocinétique AD04-103, recevant la confirmation de la FDA pour sa stratégie de pont 505(b)(2) et avançant vers des essais de Phase 3 en 2025.
Les points financiers saillants incluent :
- Position de trésorerie de $3,8 millions au 31 décembre 2024 (en hausse par rapport à $2,8 millions en 2023)
- Perte nette augmentée à $13,2 millions (comparé à $5,1 millions en 2023)
- Les dépenses de R&D ont augmenté de $1,9 millions (155%)
- Les dépenses générales et administratives ont diminué de $491,000 (9%)
L'entreprise a renforcé son portefeuille de propriété intellectuelle avec trois nouveaux brevets américains couvrant des approches basées sur la génétique pour traiter l'AUD et d'autres dépendances. Adial a établi un partenariat avec Boudicca Dx pour le développement de tests diagnostiques complémentaires et a nommé Vinay Shah au poste de CFO.
Adial Pharmaceuticals (NASDAQ: ADIL) hat die Ergebnisse des Geschäftsjahres 2024 und wichtige Entwicklungen in seinem AD04-Programm zur Behandlung von Alkoholgebrauchsstörungen (AUD) bekannt gegeben. Das Unternehmen hat die AD04-103-Pharmakokinetik-Studie erfolgreich abgeschlossen, erhielt die Bestätigung der FDA für seine 505(b)(2)-Bridging-Strategie und schreitet auf die Phase-3-Studien im Jahr 2025 zu.
Finanzielle Höhepunkte umfassen:
- Liquiditätsposition von $3,8 Millionen zum 31. Dezember 2024 (im Vergleich zu $2,8 Millionen im Jahr 2023)
- Der Nettoverlust stieg auf $13,2 Millionen (im Vergleich zu $5,1 Millionen im Jahr 2023)
- F&E-Ausgaben stiegen um $1,9 Millionen (155%)
- Allgemeine und administrative Ausgaben sanken um $491.000 (9%)
Das Unternehmen hat sein IP-Portfolio mit drei neuen US-Patenten gestärkt, die genetisch basierte Ansätze zur Behandlung von AUD und anderen Drogenabhängigkeiten abdecken. Adial hat sich mit Boudicca Dx zusammengetan, um begleitende diagnostische Tests zu entwickeln, und Vinay Shah als CFO ernannt.
- FDA approval of 505(b)(2) bridging strategy for Phase 3 trials
- Secured three new US patents strengthening IP portfolio
- Cash position increased to $3.8M from $2.8M YoY
- Successful completion of AD04-103 PK study
- 9% reduction in G&A expenses
- Net loss increased to $13.2M from $5.1M YoY
- R&D expenses surged 155% YoY
- Current cash only funds operations until H2 2025
- $4.5M non-cash inducement expense incurred
Insights
Adial Pharmaceuticals has achieved several critical regulatory and clinical milestones that meaningfully de-risk their AD04 development program for Alcohol Use Disorder (AUD). The successful completion of their pharmacokinetics study and subsequent FDA confirmation of their proposed 505(b)(2) bridging strategy represents significant progress toward initiating pivotal Phase 3 trials in 2025. This regulatory pathway allows Adial to leverage existing safety data for ondansetron, potentially accelerating development timelines and reducing costs.
The company has strengthened its intellectual property position with three new US patents that expand coverage of their genetic-based approach to treating AUD and other dependencies. These patents protect their precision medicine strategy of identifying patients with specific genetic markers who are most likely to respond to AD04 treatment. The partnership with Boudicca Dx for companion diagnostic development further supports this approach and enhances the regulatory package.
From a clinical perspective, Adial's non-abstinence approach aligns with NIAAA's updated recovery definition, potentially expanding the addressable market. However, investors should note the $13.2M net loss and current cash runway extending only into H2 2025. With Phase 3 trials planned for this year, additional financing will likely be required, creating potential dilution risk. The 155% increase in R&D expenses reflects appropriate investment in clinical development but will require careful cash management moving forward.
Adial's fiscal 2024 results highlight both progress and financial challenges. The $3.8M cash position as of December 31, 2024 represents a modest improvement from $2.8M the previous year, but the runway only extends into the second half of 2025. With Phase 3 trials planned for 2025, which typically require significant capital, the company will likely need additional financing in the near term.
The $13.2M net loss for 2024 represents a substantial increase from the $5.1M loss in 2023. This widening deficit was primarily driven by $4.5M in non-cash inducement expenses, a $0.6M loss on equity investment, and a 155% increase in R&D expenses to support the PK study and manufacturing preparations. While R&D investment is appropriate given the development stage, the acceleration of spending necessitates careful financial planning.
The company demonstrated some cost discipline with a 9% reduction in G&A expenses, driven by lower legal costs and compensation. The appointment of experienced CFO Vinay Shah could further strengthen financial operations and potential fundraising efforts. The FDA's confirmation of the 505(b)(2) pathway potentially improves the company's valuation proposition by reducing development costs and timelines.
The expanded patent portfolio enhances Adial's commercial potential and partnership attractiveness, which could be critical for securing non-dilutive financing through strategic partnerships. However, with a micro-cap valuation of under $5M, the company faces substantial financing challenges as it approaches capital-intensive late-stage development, despite the promising regulatory progress.
GLEN ALLEN, Va., March 04, 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 2024 fiscal year ended December 31, 2024.
Key Highlights
- Successful completion of AD04-103 pharmacokinetics (PK) study of AD04, corroborating bioavailability, dose proportionality, no food effect, and safety profile consistent with the use of Ondansetron.
- Advancement towards pivotal Phase 3 trial design supportive of ongoing partnership discussions.
- FDA confirmation of proposed 505(b)(2) bridging strategy leveraging the results from AD04-103—a relative bioavailability food-effect study—along with in vitro dissolution data demonstrating equivalence between the reference product and the planned commercial formulation of AD04.
- FDA positive response confirms that design of data package would meet the requirements necessary to allow for the progression of AD04 into Phase 3 clinical trials.
- FDA positive response confirms that design of data package would meet the requirements necessary to allow for the progression of AD04 into Phase 3 clinical trials.
- With FDA confirmation, Adial is commencing manufacturing of clinical supplies for Phase 3 clinical program in 2025.
- Secured several foundational patents, strengthening IP portfolio in support of commercialization of AD04, including:
- New U.S. patent granted expanding coverage of Adial’s genetic-based approach to treating and diagnosing Alcohol Use Disorder (AUD) and other drug dependencies.
- New U.S. Patent granted covering genotype-specific treatment of opioid-related disorders.
- New U.S. Patent granted for the treatment of alcohol and drug dependence based on expanded genotype combinations.
- New U.S. patent granted expanding coverage of Adial’s genetic-based approach to treating and diagnosing Alcohol Use Disorder (AUD) and other drug dependencies.
“We achieved meaningful milestones in 2024, leading to positive feedback from the U.S. Food and Drug Administration (FDA) regarding our proposed 505(b)(2) bridging strategy and the initiation of clinical supply manufacturing for our upcoming Phase 3 trial this year,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “A key achievement was the completion of our pharmacokinetics (PK) study evaluating AD04, our investigational drug for the treatment of Alcohol Use Disorder (AUD). This study assessed the PK profile, bioavailability, and food effect of AD04 near-micro doses compared to marketed Ondansetron in healthy volunteers. The findings enabled the FDA to confirm the bridging requirements for our 505(b)(2) registration pathway and support our planned micro-dosing regimen for the upcoming registrational trials.”
“In addition to the key highlights mentioned, we strengthened our regulatory strategy by partnering with Boudicca Dx to advance the development of our companion diagnostic genetic test for AD04. Boudicca Dx, a global leader in precision medicine testing, has been instrumental in ensuring our test meets FDA technical and clinical validation standards. This collaboration played an important role in our discussions with the FDA and further solidified our regulatory pathway.”
"With these foundational steps in place, we are well-positioned to initiate our Phase 3 clinical trials in 2025. Our focus remains on advancing AD04 as efficiently as possible to provide a much-needed treatment option for individuals struggling with addiction,” concluded Mr. Claiborne.
Other Developments
Management
On November 5, 2024, Adial announced the appointment of Vinay Shah as the Company’s Chief Financial Officer. Mr. Shah is an accomplished Chief Financial Officer with over 25 years of experience in the pharmaceutical, biopharmaceutical, and healthcare sectors, specializing in financial strategy, investor relations, and operational efficiency.
Intellectual Property
On February 19, 2025, Adial announced patent number 12,226,401 was issued on February 18, 2025, by the United States Patent and Trademark Office (USPTO). The patent covers claims that focus on a method for identifying genetic markers in patients with alcohol or opioid-related disorders including the AC genotype of rs17614942 in the HTR3B gene and the AG genotype of rs1150226 in the HTR3A gene.
On February 12, 2025, Adial announced patent number 12,221,654 was issued on February 11, 2025, by the USPTO. This patent expands the covered methods of identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04. The treatment approach involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04.
On December 3, 2024, Adial announced patent number 12,150,931 was issued on November 26, 2024, by the USPTO. The patent covers a broader range of genotype combinations identified by the Company’s proprietary genetic diagnostic for targeted treatment of alcohol use disorder (AUD) with AD04. These genotype combinations include the HTR3A, HTR3B, and SLC6A4 receptor sites.
Commendation
On October 15, 2024, Adial applauded the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its newly updated definition of recovery. The new definition, outlined and emphasized in NIAAA’s 2025 Professional Judgement Budget (PJB) as reported to the U.S. Congress following an original introduction in an NIAAA PJB, emphasizes a broader, non-abstinence approach to recovery, which aligns directly with Adial’s AD04 program, which has the potential to offer patients the flexibility of reducing drinking and, or abstinence.
Fiscal Year 2024 Financial Results
- Cash and cash equivalents were
$3.8 million as of December 31, 2024, compared to$2.8 million as of December 31, 2023. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2025 based on currently committed development plans. - Research and development expenses increased by approximately
$1.9 million (155% ) during the year ended December 31, 2024, compared to the year ended December 31, 2023. The key drivers of this increase were an increase of approximately$1.4 million of direct clinical trial expenses associated with the PK study initiated in 2024, and an increase of approximately$813 thousand of chemistry, manufacturing, and controls (CMC) expenses, as stability testing took place to support the PK study in 2024, and drug product manufacturing was initiated to support the upcoming Phase 3 clinical program. - General and administrative expenses decreased by approximately
$491 thousand (9% ) during the year ended December 31, 2024, compared to the year ended December 31, 2023. This decrease was the result of lower corporate legal expenses of approximately$269 thousand and a decrease in compensation of approximately$215 thousand , including equity-based compensation of G&A personnel. - Net Loss was
$13.2 million for the year ended December 31, 2024, compared to a net loss of$5.1 million for the year ended December 31, 2023. The increase in net loss was primarily driven by non-cash charges of$4.5 million for an inducement expense and$0.6 million loss on our equity method investment along with increases in R&D spending offset by a decrease in G&A 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 being well-positioned to initiate Phase 3 clinical trials in 2025, advancing AD04 as efficiently as possible to provide a much-needed treatment option for individuals struggling with addiction, existing cash and cash equivalents funding operating expenses into the second half of 2025 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.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: ADIL@crescendo-ir.com
FAQ
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