Adial Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q3 2024 financial results and business updates. The company achieved database lock for AD04's pharmacokinetics study in Alcohol Use Disorder (AUD) treatment. Cash position stood at $5.2 million as of September 30, 2024, expected to fund operations into H2 2025. Q3 net loss increased to $2.2 million from $1.4 million year-over-year. R&D expenses rose 399% due to clinical trial and CMC costs. The company partnered with Boudicca Dx for companion diagnostic development and secured new patent allowances.
Adial Pharmaceuticals (NASDAQ: ADIL) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha raggiunto la chiusura del database per lo studio di farmacocinetica di AD04 nel trattamento del disturbo da uso di alcol (AUD). La posizione di cassa si attestava a 5,2 milioni di dollari al 30 settembre 2024, con previsioni che consentono di finanziare le operazioni fino al secondo semestre del 2025. La perdita netta nel terzo trimestre è aumentata a 2,2 milioni di dollari da 1,4 milioni di dollari rispetto all'anno precedente. Le spese di R&S sono aumentate del 399% a causa dei costi dei trial clinici e dei CMC. L'azienda ha stipulato una partnership con Boudicca Dx per lo sviluppo di diagnostica companion e ha ottenuto nuove concessioni di brevetto.
Adial Pharmaceuticals (NASDAQ: ADIL) reportó resultados financieros y actualizaciones comerciales del tercer trimestre de 2024. La empresa logró el cierre de la base de datos para el estudio de farmacocinética de AD04 en el tratamiento del trastorno por consumo de alcohol (AUD). La posición de efectivo se situó en 5.2 millones de dólares al 30 de septiembre de 2024, con la expectativa de financiar las operaciones hasta la segunda mitad de 2025. La pérdida neta del tercer trimestre aumentó a 2.2 millones de dólares desde 1.4 millones de dólares en comparación con el año anterior. Los gastos de I+D aumentaron un 399% debido a los costos de ensayos clínicos y CMC. La empresa se asoció con Boudicca Dx para el desarrollo de diagnósticos complementarios y aseguró nuevas concesiones de patentes.
Adial Pharmaceuticals (NASDAQ: ADIL)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 이 회사는 알코올 사용 장애 (AUD) 치료를 위한 AD04의 약물 동태 연구에 대한 데이터베이스 잠금을 달성했습니다. 2024년 9월 30일 기준 현금 보유액은 520만 달러였으며, 2025년 하반기까지 운영 자금을 확보할 것으로 예상됩니다. 3분기 순손실은 전년 대비 220만 달러로 증가했습니다. 연구 개발 비용은 임상 시험 및 CMC 비용으로 인해 399% 증가했습니다. 이 회사는 동반 진단 개발을 위해 Boudicca Dx와 파트너십을 체결하고 새로운 특허 허가를 확보했습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a publié les résultats financiers et les mises à jour commerciales du troisième trimestre 2024. L'entreprise a atteint le verrouillage de la base de données pour l'étude de pharmacocinétique d'AD04 dans le traitement du trouble de l'utilisation de l'alcool (AUD). La position de trésorerie s'élevait à 5,2 millions de dollars au 30 septembre 2024, avec une prévision de financement des opérations jusqu'au deuxième semestre 2025. La perte nette du troisième trimestre a augmenté à 2,2 millions de dollars contre 1,4 million de dollars par rapport à l'année précédente. Les dépenses de R&D ont augmenté de 399% en raison des coûts des essais cliniques et des CMC. L'entreprise a établi un partenariat avec Boudicca Dx pour le développement de diagnostics compagnons et a obtenu de nouveaux permis de brevet.
Adial Pharmaceuticals (NASDAQ: ADIL) berichtete über die finanziellen Ergebnisse und Unternehmensupdates für das 3. Quartal 2024. Das Unternehmen erreichte den Datenbankschluss für die Pharmakokinetik-Studie von AD04 zur Behandlung des Alkoholgebrauchsstörung (AUD). Die Liquiditätsposition betrug zum 30. September 2024 5,2 Millionen Dollar, was voraussichtlich die Finanzierung der Betriebe bis in die zweite Hälfte von 2025 ermöglichen wird. Der Nettoverlust im 3. Quartal stieg auf 2,2 Millionen Dollar im Vergleich zu 1,4 Millionen Dollar im Vorjahr. Die F&E-Ausgaben stiegen um 399% aufgrund der Kosten für klinische Studien und CMC. Das Unternehmen ging eine Partnerschaft mit Boudicca Dx für die Entwicklung von Begleitdiagnostika ein und sicherte sich neue Patentgenehmigungen.
- Successful database lock of AD04 pharmacokinetics study, advancing toward commercialization
- Cash position increased to $5.2M from $2.8M at year-end 2023
- Secured $3.8M through ATM facility in Q3
- New patent allowance strengthening IP protection through 2044
- Strategic partnership with Boudicca Dx for diagnostic development
- Net loss increased to $2.2M from $1.4M year-over-year
- R&D expenses increased 399% to $825K
- G&A expenses increased 3% ($29K)
- Ongoing share dilution through ATM facility usage
Insights
The Q3 financial results reveal concerning trends. The
The completion of database lock for AD04's pharmacokinetics study marks a important development milestone. This study will validate essential dosing parameters and safety profiles, critical elements for regulatory advancement. The partnership with Boudicca Dx for companion diagnostic development demonstrates strategic foresight in personalizing AUD treatment through genetic screening. The NIAAA's broader definition of recovery could significantly impact AD04's market potential by expanding the acceptable treatment outcomes beyond complete abstinence. However, the substantial increase in R&D spending, particularly the
GLEN ALLEN, Va., Nov. 13, 2024 (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 2024.
Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We reached an important milestone this quarter with the successful database lock of the pharmacokinetics study for AD04, our lead investigational, genetically targeted therapeutic for the treatment of Alcohol Use Disorder (AUD). The pharmacokinetics study is essential for validating AD04’s dosing and safety profile, and we expect to report topline results soon. This accomplishment would position us to begin regulatory preparations, reinforcing our mission to bring a safe, effective AUD treatment to market.”
“Building on our commitment to personalized addiction care, we have entered into a strategic partnership with Boudicca Dx to support the development plan for our companion diagnostic genetic test and help ensure compliance with FDA guidelines. This innovative tool is designed to identify genetic markers that indicate a patient’s responsiveness to AD04, paving the way for more targeted and effective treatment options.”
“Furthermore, the National Institute on Alcohol Abuse and Alcoholism recently introduced a new, broader definition of recovery, which expands the concept beyond abstinence alone. This inclusive perspective acknowledges the various paths individuals may take in their recovery journeys. By aligning with this comprehensive definition, we are optimistic that it will stimulate additional support for programs like AD04. Overall, we are proud of the meaningful progress made during the quarter and believe we are making progress in advancing AD04 toward commercialization,” concluded Mr. Claiborne.
Other Developments
Management
On November 5, 2024, Adial announced the appointment of Vinay Shah as Chief Financial Officer, effective November 16, 2024.
Patents
On October 17, 2024, Adial announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a new patent. The patent, once issued, will cover additional genotype combinations identified through the Company’s proprietary genetic diagnostic tool.
On July 31, 2024, Adial announced that, after an extensive review of data and information from the Onward Study, it had filed a new patent application to protect core assets and extend IP exclusivity on its core technology. This patent, assuming granted, is expected to protect Adial’s core assets through at least 2044.
Financing
During the third quarter the Company received total gross proceeds of approximately
Third Quarter 2024 Financial Results
- Cash and cash equivalents were
$5.2 million as of September 30, 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
$825 thousand (399% ) in the three months ended September 30, 2024, compared to the three months ended September 30, 2023. This change was due to an increase of approximately$771 thousand in clinical trial expenses related to the pharmacokinetics (PK) study during the quarter and chemistry, manufacturing, and controls (CMC) expenses which increased by approximately$204 thousand , as stability testing took place to support the PK study. These increases were partially offset by modest decreases in license royalty expense and decreases in the salaries and equity-based compensation of R&D personnel. - General and administrative expenses increased by approximately
$29 thousand (3% ) in the three months ended September 30, 2024, compared to the three months ended September 30, 2023. - Net Loss was
$2.2 million for the three months ended September 30, 2024, compared to a net loss of$1.4 million for the three months ended September 30, 2023. The increase in Net Loss was primarily driven by the increases in R&D and G&A expenses described above.
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.
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 reporting topline results from the pharmacokinetics study of AD04 soon, beginning regulatory preparations, bringing a safe, effective AUD treatment to market, ensuring compliance with FDA guidelines, identify genetic markers that indicate a patient’s responsiveness to AD04, paving the way for more targeted and effective treatment options, the broader definition of recovery stimulating additional support for programs like AD04, making progress in advancing AD04 toward commercialization, the new patent application protecting core assets through at least 2044, existing cash and cash equivalents funding operating expenses into the second half of 2025 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, 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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