Enveric Biosciences Reports Second Quarter 2024 Financial and Corporate Results

Rhea-AI Summary

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

Positive

• Prioritization of EB-003 as lead development candidate with potential for first-in-class neuroplastogenic molecule
• Preclinical results confirming oral bioavailability and significant brain exposure of EB-003
• Expanded business development activities with multiple deals in advanced stages
• Licensing agreement signed with Aries Science & Technology for radiation dermatitis product
• Reduced net loss to $1.7 million in Q2 2024 from $6.40 million in Q2 2023

Negative

• Net loss of $1.7 million for Q2 2024
• Cash-on-hand of $3.5 million as of June 30, 2024, which may be insufficient for long-term operations

Insights

Financial Analyst

Enveric Biosciences' Q2 2024 results show a significant reduction in net loss to $1.7 million from $6.4 million in Q2 2023, indicating improved financial management. The cash position of $3.5 million is concerning, potentially necessitating additional funding soon to support ongoing R&D efforts.

The company's focus on EB-003 as its lead candidate and potential non-dilutive revenue from licensing deals could be positive catalysts. However, with IND filing and clinical trials not expected until 2025, Enveric faces a long runway to potential commercialization. Investors should closely monitor cash burn and potential dilution risks in the coming quarters.

Medical Research Analyst

Enveric's prioritization of EB-003, a non-hallucinogenic neuroplastogenic molecule, represents a strategic shift in the psychedelic-derived drug space. The oral bioavailability and significant brain exposure in preclinical studies are promising, potentially addressing key challenges in psychedelic therapies.

The company's aim to conduct blinded placebo-controlled trials and potentially offer outpatient administration without psychotherapy support could be game-changing if successful. However, the lack of specific efficacy data and the early stage of development (pre-IND) suggest a long and uncertain path ahead. Investors should remain cautious until more concrete clinical data emerges.

Business Development Expert

Enveric's expanded business development activities, including multiple licensing deals in advanced stages, demonstrate a proactive approach to monetizing its AI-backed drug discovery engine. The licensing agreement with Aries Science & Technology for the radiation dermatitis product and non-binding term sheets for other compounds could provide crucial non-dilutive revenue.

This strategy could help offset R&D costs and extend the cash runway, potentially reducing the need for dilutive financing. However, the non-binding nature of several deals and lack of disclosed financial terms make it difficult to quantify the potential impact. Investors should watch for the conversion of these term sheets into definitive agreements and their financial terms.

Prioritized EB-003 as lead development candidate. EB-003 is a novel, non-hallucinogenic neuroplastogenic molecule designed to treat severe mental health disorders

Announced preclinical results confirming oral bioavailability and significant brain exposure of EB-003, supporting expedited development strategy

Expanded business development activities to maximize assets developed using AI-backed drug discovery engine, with multiple deals in advanced stages offering potential to contribute value to stockholders

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 provided a corporate update and reported financial results for the second quarter ended June 30, 2024.

“The second quarter of 2024 was marked by the prioritization of EB-003 as our lead development candidate. This strategic decision was made based on the potential for EB-003 to be a first-in-class neuroplastogenic molecule that can address multiple, difficult-to-treat mental health disorders without inducing the hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and related analogs,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We believe EB-003’s differentiated properties set it apart from other drugs in this class and address many of the challenges facing psychedelic-derived drugs, including the ability to conduct truly blinded placebo-controlled clinical trials and the potential to administer the therapy in an outpatient setting without psychotherapy support. Adding to the excitement with EB-003, recently completed pre-clinical research indicated the potential for the drug candidate to be delivered via oral administration and penetrate the brain at levels expected to elicit the desired therapeutic effect.”

Dr. Tucker continued, “Given the value potential of EB-003, we are accelerating its evaluation in several in vivo animal efficacy models to determine the optimal therapeutic indication for clinical development and expected dose range as we prepare for a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration in early 2025. This timeline should then allow for the filing of an IND application by the third quarter of 2025 and initiation of a first-in-human clinical trial of EB-003 by the end of 2025.”

Dr. Tucker concluded, “Complementing our EB-003 development efforts, during the second quarter we expanded our initiative to secure out-licensing opportunities involving proprietary drug candidates identified through Enveric’s drug discovery engine and other compounds owned by the company. We were pleased to enter into a licensing agreement with Aries Science & Technology for our patented radiation dermatitis topical product and enter into a number of non-binding term sheets, which collectively have the potential to generate non-dilutive revenue, which could support Enveric’s ability to advance its lead asset, EB-003, and further build stockholder value.”

SECOND QUARTER AND RECENT UPDATES

Corporate, Product and Business Development Highlights:

• Signed non-binding term sheets to pursue the exclusive out-licensing of new chemical entities for pharmaceutical and non-pharmaceutical applications in joint disease
• Signed non-binding term sheet with undisclosed licensee for the exclusive license to patented methods of treating breast and other cancers using cannabinoids
• Provided strategic outlook and pipeline update, elevating EB-003 to lead development candidate
• Confirmed oral bioavailability and significant brain exposure preclinical studies of EB-003, supporting expedited development with IND filing and first patient dosed expected in 2025
• Announced patent granted for drug candidate
• Signed licensing agreement with Aries Science & Technology with plans to clinically develop and market Enveric’s patented product for radiation dermatitis

SECOND QUARTER FINANCIAL RESULTS

Net loss attributable to stockholders was $1.7 million for the second quarter ended June 30, 2024, including $0.4 million in net non-cash expense, with a basic and diluted loss per share of $0.23, as compared to a net loss of $6.40 million, including $1.6 million in net non-cash expense, with a basic and diluted loss per share of $3.04 for the quarter ended June 30, 2023. The Company had cash-on-hand of $3.5 million for the quarter ended June 30, 2024.

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, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of 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,” “explores,” “schedules,” “seeks,” “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 the 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240812797182/en/

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 Enveric Biosciences' lead development candidate?

Enveric Biosciences' lead development candidate is EB-003, a novel, non-hallucinogenic neuroplastogenic molecule designed to treat severe mental health disorders.

When does Enveric Biosciences (ENVB) expect to file an IND for EB-003?

Enveric Biosciences expects to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025.

What was Enveric Biosciences' (ENVB) net loss for Q2 2024?

Enveric Biosciences reported a net loss of $1.7 million for the second quarter ended June 30, 2024.

What licensing agreement did Enveric Biosciences (ENVB) sign in Q2 2024?

Enveric Biosciences signed a licensing agreement with Aries Science & Technology for its patented radiation dermatitis topical product.