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Enveric Biosciences Presents Data Highlighting Development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop

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Enveric Biosciences (NASDAQ: ENVB) presented data on its lead candidate, EB-003, at the European Behavioral Pharmacology Society Biennial Workshop in Banff, Canada. The preclinical research highlights EB-003's anxiolytic and anti-depressant properties without inducing hallucinations, a favorable profile compared to other DMT analogs. The study involved behavioral outcomes in mice, showing positive results in models for anxiety and depression. Key measures included head twitch response (HTR), marble burying, and sucrose preference. Enveric aims to file an IND application for EB-003 by Q3 2025 and start clinical trials by the end of 2025. The presentation was delivered by Peter Facchini, Ph.D., Chief Innovation Officer.

Enveric Biosciences (NASDAQ: ENVB) ha presentato dati sul suo candidato principale, EB-003, durante il Workshop Biennale della Società Europea di Farmacologia Comportamentale a Banff, Canada. La ricerca preclinica mette in risalto le proprietà ansiolitiche e antidepressivi di EB-003, senza indurre allucinazioni, un profilo favorevole rispetto ad altri analoghi del DMT. Lo studio ha coinvolto risultati comportamentali in topi, mostrando risultati positivi in modelli di ansia e depressione. Le misure chiave includevano la risposta al twitch della testa (HTR), il seppellimento delle biglie e la preferenza per il saccarosio. Enveric punta a presentare una domanda IND per EB-003 entro il terzo trimestre del 2025 e a iniziare gli studi clinici entro la fine del 2025. La presentazione è stata effettuata da Peter Facchini, Ph.D., Chief Innovation Officer.

Enveric Biosciences (NASDAQ: ENVB) presentó datos sobre su candidato principal, EB-003, en el Taller Bienal de la Sociedad Europea de Farmacología Conductual en Banff, Canadá. La investigación preclínica resalta las propiedades ansiolíticas y antidepresivas de EB-003 sin inducir alucinaciones, un perfil favorable en comparación con otros análogos del DMT. El estudio implicó resultados conductuales en ratones, mostrando resultados positivos en modelos de ansiedad y depresión. Las medidas clave incluyeron la respuesta de sacudida de cabeza (HTR), el enterramiento de canicas y la preferencia por el azúcar. Enveric tiene como objetivo presentar una solicitud IND para EB-003 para el tercer trimestre de 2025 y comenzar ensayos clínicos para finales de 2025. La presentación fue realizada por Peter Facchini, Ph.D., Director de Innovación.

엔버릭 바이오사이언스 (NASDAQ: ENVB)는 캐나다 밴프에서 열린 유럽 행동 약리학회 비엔날레 워크숍에서 자사의 주요 후보물질인 EB-003에 관한 데이터를 발표했습니다. 이 전임상 연구는 EB-003의 불안 감소 및 항우울 효과를 강조하며, 환각을 유도하지 않는다는 점에서 다른 DMT 유사체에 비해 유리한 프로파일을 가지고 있습니다. 이 연구는 생쥐를 대상으로 한 행동 결과를 포함하며, 불안과 우울증 모델에서 긍정적인 결과를 보여주었습니다. 주요 측정 항목에는 머리 떨림 반응 (HTR), 대리석 묻기 및 설탕 선호도가 포함되었습니다. 엔버릭은 2025년 3분기까지 EB-003에 대한 IND 신청을 제출하고 2025년 말까지 임상 시험을 시작할 계획입니다. 발표자는 Peter Facchini 박사, 혁신 최고 책임자였습니다.

Enveric Biosciences (NASDAQ: ENVB) a présenté des données sur son candidat principal, EB-003, lors de l'Atelier Biennal de la Société Européenne de Pharmacologie Comportementale à Banff, Canada. La recherche préclinique met en avant les propriétés anxiolytiques et antidépresseurs d'EB-003 sans induire d'hallucinations, un profil favorable par rapport à d'autres analogues du DMT. L'étude a impliqué des résultats comportementaux chez des souris, montrant des résultats positifs dans des modèles d'anxiété et de dépression. Les mesures clés comprenaient la réponse de secousse de la tête (HTR), l'enfouissement de billes et la préférence pour le saccharose. Enveric prévoit de déposer une demande IND pour EB-003 d'ici le troisième trimestre 2025 et de commencer des essais cliniques d'ici la fin de 2025. La présentation a été faite par Peter Facchini, Ph.D., Directeur de l'Innovation.

Enveric Biosciences (NASDAQ: ENVB) hat Daten zu seinem Hauptkandidaten EB-003 auf dem Biennale-Workshop der Europäischen Gesellschaft für Verhaltenspharmakologie in Banff, Kanada, präsentiert. Die präklinische Forschung hebt die angstlösenden und antidepressiven Eigenschaften von EB-003 hervor, ohne halluzinogene Effekte zu induzieren, was ein günstiges Profil im Vergleich zu anderen DMT-Analoga darstellt. Die Studie umfasste Verhaltensausgänge bei Mäusen und zeigte positive Ergebnisse in Modellen für Angst und Depression. Zu den wichtigen Messungen gehörten die Kopfzuckenreaktion (HTR), das Vergraben von Murmeln und die Zuckerpräferenz. Enveric plant, bis zum dritten Quartal 2025 einen IND-Antrag für EB-003 einzureichen und bis Ende 2025 klinische Studien zu starten. Die Präsentation wurde von Peter Facchini, Ph.D., Chief Innovation Officer, gehalten.

Positive
  • Presentation of promising preclinical data on EB-003 at a key scientific workshop.
  • EB-003 shows anxiolytic and anti-depressant properties without hallucinations.
  • Key behavioral measures in mice indicate potential effectiveness for anxiety and depression.
  • Plan to file an IND application by Q3 2025 and start clinical trials by end of 2025.
Negative
  • None.

Selection of EB-003 based on research indicating its non-hallucinogenic, anxiolytic and anti-depressant properties

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced that it is presenting research describing the Company’s identification of EB-003 as its lead development candidate based on preclinical data suggesting the compound exhibits promising anxiolytic and anti-depressant properties without inducing hallucinations, a favorable profile compared with other analogs of N,N-Dimethyltryptamine (DMT). The poster is being presented by Peter Facchini, Ph.D. Chief Innovation Officer of Enveric at the European Behavioral Pharmacology Society Biennial Workshop being held in Banff, Alberta, Canada on September 26, 2024.

The presentation titled, “Semi-systematic series of DMT analogs for exploring relationships between hallucination, neuroplastigenicity, and positive behavioural outcomes in mice,” describes the methodology used by Enveric to select EB-003 from a series of 3D-designed analogs based on behavioral outcomes in mouse models for anxiety and depression. The presentation highlights key measures of responses in mice including head twitch response (HTR), which is a behavioral proxy in rodents for human hallucinogenic effects, as well as outcomes of marble burying and sucrose preference, widely used models for anxiety and depression, respectively. These findings provide evidence of beneficial neuroplastogenic responses that are non-hallucinogenic in animal models.

“The European Behavioral Pharmacology Society’s Biennial Workshop is an important meeting of researchers dedicated to bringing cutting-edge pharmacology-based interventions for substance use and related mental health disorders to the forefront of medicine,” said Dr. Facchini. “I am proud to be presenting our team’s latest findings on EB-003 to the research community, and we look forward to building upon our continued efforts to move EB-003 to clinical trials.”

Enveric recently announced preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment for psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “ “budgets,” “schedules,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.

A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What is the significance of Enveric's presentation on EB-003?

Enveric presented data showing EB-003's promising anxiolytic and anti-depressant properties without inducing hallucinations, which is favorable compared to other DMT analogs.

When does Enveric plan to file an IND application for EB-003?

Enveric plans to file an IND application for EB-003 by the third quarter of 2025.

What are the key behavioral measures used in Enveric's study on EB-003?

The key behavioral measures include head twitch response (HTR), marble burying, and sucrose preference in mice.

What are the next steps for EB-003 after the preclinical findings?

Enveric expects to initiate clinical development of EB-003 by the end of 2025.

Enveric Biosciences, Inc.

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