Enveric Biosciences Inc Stock Price, News & Analysis

Enveric Biosciences (NASDAQ: ENVB) announces the expansion of patent protection for its EVM301 portfolio through five new US patents and three patent application allowances. The company now holds nine total US patents covering its drug candidate library. The patents cover various tryptamine derivative molecules, including carboxylated, aminated, prenylated, glycosylated, nitrilated, and halogenated derivatives. The company's lead candidate, EB-003, targeting treatment-resistant depression and anxiety, is in preclinical development with planned IND filing in 2025. The compound shows potential for promoting neuroplasticity without inducing hallucinations.

Enveric Biosciences (NASDAQ: ENVB) has announced positive results from preclinical safety and pharmacology studies for its lead drug candidate, EB-003. The in vitro studies confirmed EB-003's selective activity with desired serotonergic neuroreceptors and showed a low potential for undesirable cardiovascular, respiratory, and neurological reactions or drug-to-drug interactions.

Key findings include:

• No significant off-target interactions detected
• No meaningful activity against hERG or 5-HT2B, targets related to cardiovascular adverse drug reactions
• No activity against the M1 muscarinic acetylcholine receptor, related to CNS adverse drug reactions

These results, combined with previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models, enhance confidence in EB-003's potential. Enveric plans to begin in vivo toxicology and safety pharmacology activities in Q4 2024, with an expected IND application filing by Q3 2025 and clinical development initiation by the end of 2025.

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) presented data on its lead product candidate, EB-003, at the 7th Neuropsychiatric Drug Summit. EB-003 is a non-hallucinogenic, neuroplastogenic DMT analog that has shown positive outcomes in animal models of anxiety and depression. The presentation highlighted:

1. Preclinical data demonstrating EB-003's effectiveness in reducing anxiety and depression in mouse models.
2. Research on head twitch response (HTR), a behavioral proxy for hallucinogenic effects in humans.
3. Recent data confirming EB-003's oral bioavailability and ability to produce brain exposure at therapeutically relevant levels.

Enveric plans to file an Investigational New Drug (IND) application for EB-003 by Q3 2025 and initiate clinical development by the end of 2025. The company believes EB-003 is highly differentiated from similar drugs in development and has potential to be a significant value driver.

Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focusing on neuroplastogens for neuropsychiatric disorders, will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. CEO Joseph Tucker, Ph.D., will deliver a virtual presentation on September 9 at 7:00 AM ET, discussing:

• Development of novel neuroplastogenic small-molecule therapeutics for depression, anxiety, and addiction disorders
• Recent data on lead candidate EB-003, confirming oral bioavailability and significant brain exposure
• Enveric's strategy to maximize value from assets developed using their AI-backed drug discovery engine

Investors can register for the conference at https://hcwevents.com/annualconference/

Enveric Biosciences (NASDAQ: ENVB) and Aries Science & Technology announced the issuance of Patent No. 12,059,393 to Enveric's subsidiary, Akos Biosciences, for a topical product aimed at treating radiation dermatitis. This condition affects approximately two million cancer patients annually, with a market opportunity estimated at $400 million. The patent issuance follows a Licensing Agreement between Aries and Akos for the clinical development of the CBD-based lotion. Aries is forming a subsidiary to advance this opportunity, with Dr. Hari Harikumar nominated as Chairman-elect. Under the agreement terms, Enveric could receive up to $61 million in milestone payments and tiered royalties ranging from 2.5% to 10% on future sales.

Enveric Biosciences (NASDAQ: ENVB) reported Q2 2024 financial results and provided a corporate update. The company prioritized EB-003 as its lead development candidate, a novel non-hallucinogenic neuroplastogenic molecule for treating severe mental health disorders. Preclinical results confirmed EB-003's oral bioavailability and significant brain exposure, supporting an expedited development strategy.

Key highlights include:

• Expanded business development activities with multiple deals in advanced stages
• Signed licensing agreement with Aries Science & Technology for radiation dermatitis product
• Targeting IND filing for EB-003 by Q3 2025 and first-in-human trial by end of 2025
• Q2 2024 net loss of $1.7 million ($0.23 per share) compared to $6.40 million ($3.04 per share) in Q2 2023
• Cash-on-hand of $3.5 million as of June 30, 2024

Enveric Biosciences (NASDAQ: ENVB) announced promising preclinical results for EB-003, a novel neuroplastogenic molecule designed to treat severe mental health disorders without hallucinogenic effects. The study revealed good oral bioavailability and significant brain exposure in rodent models, with a brain:plasma exposure ratio of ~1.5. EB-003 also demonstrated stability against human monoamine oxidase-A (MAO-A) and in various liver microsomes, unlike DMT and similar analogs.

Based on these results, Enveric is accelerating EB-003's evaluation in animal efficacy models. The company expects to file an IND application by Q3 2025 and initiate clinical development by the end of 2025. This advancement supports Enveric's patient-centered approach, aiming to develop non-hallucinogenic treatments with favorable pharmacological properties that enhance patient adherence and reduce treatment burden.

Enveric Biosciences (NASDAQ: ENVB) and Aries Science & Technology have announced a licensing agreement for the clinical development of Enveric's patented radiation dermatitis topical product. This condition affects approximately two million cancer patients annually, with a market opportunity estimated at $400 million. The agreement includes potential milestone payments of up to $61 million and tiered royalties ranging from 2.5% to 10% on future sales for Enveric. Aries has nominated Dr. Hari Harikumar as Chairman-elect of a subsidiary formed to advance this opportunity. This partnership allows Enveric to focus on neuropsychiatric indications while Aries develops the cancer support care product.