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ENVB 10-K & 10-Q changes, risk factors and insider trading

Enveric Biosciences, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 890821 · All filings on SEC.gov

Everything below is quoted or computed from Enveric Biosciences, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

10 / 2risk-factor paragraphs added / removed in latest 10-K
4new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-27 (period ending 2025-12-31) with 10-K filed 2025-03-28 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

10new paragraphs
2removed paragraphs
55reworded paragraphs
18,828 → 18,787words in section

New heading “Business and Financial Condition”

New heading “Regulatory Matters”

New heading “Intellectual Property”

New heading “In the event Artificial Intelligence (“AI”) is used to better effect by our competitors it could lead to countervailing discoveries that may undermine our current pipeline. The use of AI could also lead to potential security risks and breaches.”

Removed heading “Our financial condition would be adversely impacted if our intangible assets become impaired”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: breach, artificial intelligence, ai
“In the event Artificial Intelligence (“AI”) is used to better effect by our competitors it could lead to countervailing discoveries that may undermine our current pipeline. The use of AI could also lead to potential security risks and breaches.”
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New text topics: penalt, breach, ai
“AI systems, if not adequately secured, could expose our company to cybersecurity threats, including data breaches, intellectual property theft, and system compromises. The exploitation of such vulnerabilities could lead to reputational damage, legal liabilities, and regulatory penalties.”
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Reworded topics: fine, regulation

Paragraph as it now reads, with added and removed wording marked:

In connection with our development and future commercialization (if applicable) of our prospective products, we, and each contemplated product drug candidate, are subject to the Federal Food Drug FDCA and Cosmeticits Actimplementing (FDCA).regulations. The FDCA isdefines intended to assure the consumer, in part, that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and the U.S. Food and Drug Administration (FDA) regulations define the terma “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The definition also includes components of drugs, such as active pharmaceutical ingredients. To be lawfully marketed in the United States, drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.process. If the FDA does not awardgrant premarket approval for our product drug candidates through the NDA process, this will have a material adverse effect on our business, financial condition and results of operations.
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Reworded topics: fine, regulation

Paragraph as it now reads, with added and removed wording marked:

We are in the process of developing investigational new drugs for which we intend to pursue FDA approval via the NDA process. In connection with our development and future commercialization (if applicable) of our products, we and each contemplated product candidate are subject to the Federal Food Drug and Cosmetic Act (FDCA).FDCA. The FDCA is intended to assure the consumer, in part, that drugs and devices are safedefines and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and FDA regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), that is claimed to be beneficial for such uses will be regulated by FDA as a drug. The definition also includes components of drugs, such as active pharmaceutical ingredients. Drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.process. If the FDA does not awardgrant premarket approval for our product drug candidates through the NDA process, this could have a material adverse effect on our business, financial condition and results of operations.
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Removed text
“Our financial condition would be adversely impacted if our intangible assets become impaired”
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Removed text topics: impairment
“Intangibles are evaluated quarterly and are tested for impairment at least annually or when events or changes in circumstances indicate the carrying value of each segment, and collectively the Company taken as a whole, might exceed its fair value. If we determine that the value of our intangible assets is less than the amounts reflected on our balance sheet, we will be required to reflect an impairment of our intangible assets in the period in which such determination is made. …”
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Full comparison: every changed paragraph (67)

Green = added, red = removed. Unchanged paragraphs, 3 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Added

A summary of the principal risk factors that make investing in our securities risky and might cause our actual results to differ materially from those projected. This summary should be read in conjunction with the complete discussion of risk factors set forth in “Item 1A. Risk Factors.” If any of the following factors occur, our business, financial condition, results of operations, cash flows, cash available for distribution, ability to service our debt obligations and prospects could be materially and adversely affected:

Added

Business and Financial Condition

Added

Regulatory Matters

Added

Intellectual Property

Added

Common Stock

Reworded

Our independent registered public accounting firm issued a report dated March 28,27, 20252026 in connection with the audit of our consolidated financial statements as of December 31, 2024,2025, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt doubt about our ability to continue as a going concern including our recurring losses, cash used in operations, and need to raise additional funds to meet our obligations and sustain our operations. In addition, the notes to our financial statements for the year ended December 31, 2024,2025, included in this Annual Report on Form 10-K,Report, contain a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us in the necessary timeframe, in the amounts we require, on terms that acceptable to us, or at all. If we are unable to raise additional capital our business, prospectus, financial condition and results of operations will be materially and adversely affected and we may be unable to continue as a going concern. If we are not able to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements and/or seek protection under federal bankruptcy law, and it is likely that holders of our common stock and holders of securities convertible into our common stock will lose all of their investment. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

Reworded

We intend to advance early research programs through preclinical development and to file an IND applicationapplications for human clinical trials evaluating the prospective product candidates in our pipeline. The preparation and submission of IND applications requires rigorous and time-consuming preclinical testing, the results of which must be sufficiently documented to establish, among other things, the toxicity, safety, manufacturing,chemistry manufacturing and chemistrycontrols (“CMC”) and clinical protocolprotocols of the product candidates. We may experience unforeseen difficulties that could delay or otherwise prevent us from successfully executing our current development strategy. In addition, our ability to complete and file certain IND applications may depend on the support of our partners and the timely performance of their obligations under relevant collaboration agreements. If our relevant partners are not able to perform such obligations, or if they otherwise delay the progress, we may not be able to prepare and file the intended IND applications on a timely basis or at all. Any delay, suspension or reduction of our efforts to pursue our preclinical and IND strategy could have a material adverse effect on our business and cause our share price to decline.

Added

In the event Artificial Intelligence (“AI”) is used to better effect by our competitors it could lead to countervailing discoveries that may undermine our current pipeline. The use of AI could also lead to potential security risks and breaches.

Added

AI technologies are evolving rapidly, and our management has limited ability to fully assess or predict the potential long-term risks and disruptions they may bring. As AI technologies continue to develop, we may face significant challenges in adapting to new market conditions or operational realities. Competitors may leverage AI to gain competitive advantages or disrupt established business models.

Added

Moreover, AI systems have the potential to make unforeseen or unintended discoveries that may disrupt existing products, services, or business strategies. These countervailing discoveries could render our current operations or offerings obsolete, or cause unforeseen consequences that are difficult to mitigate. As AI-driven developments evolve, the risk of encountering these unintended outcomes increases, and our ability to anticipate or control them may be limited.

Added

Additionally, the rapid deployment of AI by competitors could create significant competitive risks. Competitors may be able to develop or adopt AI technologies faster than we can, potentially outpacing our innovation or efficiency improvements. This could result in a loss of market share, reduced profitability, and increased difficulty in maintaining a competitive position within our industry.

Added

AI systems, if not adequately secured, could expose our company to cybersecurity threats, including data breaches, intellectual property theft, and system compromises. The exploitation of such vulnerabilities could lead to reputational damage, legal liabilities, and regulatory penalties.

Reworded

Research and development, management and administrative expenses and cash used for operations will continue to be significant and may increase substantially in the future in connection with new and continued research and development initiatives and our pursuit of IND authorizationapplication(s) for some or all of our product candidates, as is required to initiate clinical trials in human subjects in the United States. We will need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval of marketing applications, and to fund commercialization of our current and future product candidates.

Reworded

While we expect to fund our future capital requirements from financing arrangements, we cannot assure you that any such financing arrangements will be available to it on favorable terms, or at all. InOn theJanuary first27, quarter of 2025,2026, we engaged in a bestregistered effortsdirect publicoffering offering,and concurrent private placement, which locked-up our ability to issueengage securities or file registration statements for a period of 60 days following February 3, 2025, and engage in variable-rate transactions for a period of one year following FebruaryJanuary 3,27, 2025, each2026, subject to limited exceptions. Even if we can raise funds from financing arrangements, the amounts raised may not be sufficient to meet our future capital requirements. Additionally, the Company does not have sufficient unreserved, authorized shares to secure an equity investment of a sufficient amount, based on the Company’s currently traded price per share, and the Company will require shareholder approval to increase the amount of authorized shares. If we are not able to raise capital, we could be required to postpone, scale back or eliminate some, or all, of our development objectives or commercialization efforts.

Reworded

We have consolidated our employee base to save capital and focus on development of our leadinglead candidate EB-003. As of the date of this report, we employ five full-time employees and one part-time employee. We are highly dependent on our current management and scientific personnel, including Joseph Tucker, Peter Facchini, and Kevin Coveney. The inability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense and we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

Reworded

There has been limited study on the effects of psychedelic- inspired drug candidates, and future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelics.psychedelic-inspired drug candidates.

Reworded

Our limited resources have lead us to focus on a particular product candidate. As a result, we may fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of medical and commercial success.

Reworded

As a result of our limited financial, managerial and scientific leadership resources we have focused on developing product candidates that we have identified as most likely to succeed. As such, we have elected to forego or delay for the time being the development of other candidates that may prove to have greater potential. Our resource allocation decisions may cause us to fail to capitalize on viable medical solutions, therapeutic enhancements and commercial potentials for viable markets when ourbecause spending on our currentlead andcandidate futurefor defined candidatesone withor themore indications specified therein may not yield any commercially viable products. Inaccurate or limited evaluation of commercial and therapeutic potential may result in relinquishment of ofother valuable product candidate opportunity.opportunities.

Reworded

The pharmaceutical industry is highly competitive, with an emphasis on proprietary products and subject to rapid change. The industry continues to expand and evolve as an increasing number of competitors and potential competitors enter the market. Many of these competitors and potential competitors have substantially greater financial, technological, managerial and research and development resources and experience than us. Some of these competitors and potential competitors have more experience than us in the development of pharmaceutical products, including validation proceduresclinical trials and regulatory matters. In addition, our future product candidates, if successfully developed, will compete with product offerings candidates from large and well-established companies that have greater marketingcommercial and sales experience and capabilitiesexpertise than us or our collaboration partners have. Other companies with greater resources than weus may announce similar plans in the future. In addition, small or early stage companies may prove to be competitors, particularly through collaborative arrangements with large and established companies. If we are unable to compete successfully, our commercial opportunities will be reduced and our business, results of operations and financial conditions may be materially harmed. In addition, we compete with these companies in recruiting and retaining scientific personnel as well as establishing clinical trial sites and patient registration recruitment for clinical trials.

Reworded

We are conducting, or may conduct, preclinical and/or clinical studies outside the United States. To the extent we do not conduct these clinical trials in accordance under an IND application, the FDA may not accept data from such trials. Although the FDA may accept data from clinical trials conducted outside the United States that are not conducted under an IND application, the FDA’s acceptance of the data is subject to certain conditions. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles and all applicable FDA regulations. The trial population must also adequately represent the intended U.S. population, and the resulting clinical trial data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically clinically meaningful. In general, the patient population for any clinical trials conducted outside of the United States must be representative of of the population for whom we intend to market the product candidate in the United States, if approved. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the clinical trial data will be dependent upon our ability to verify the data and our determination that the clinical trials also complied with all applicable U.S. laws and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

Reworded

We cannot guarantee that the FDA will accept data from clinical trials conducted outside of the United States. If the FDA does not accept the data from such clinical trials, we would likely result in the need for additional trials and the completion of additional regulatory steps, which would be costly and time-consuming and could delay or permanently halt our development of our product candidates.

Reworded

The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourthe Company or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Reworded

The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches or interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. In the future, any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act (HIPPA) and European Union General Data Protection Regulation, government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share and monitor safety data, bill payors or patients, provide customer support services, conduct research and development activities, process and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

Reworded

As a neuro-pharmaceutical drug discovery and development platform company, the Company expects to spend substantial funds on the research, development and testing of psychedelic-inspired drug candidates. In addition, the Company expects to incur significant ongoing costs and obligations related to its investment in infrastructure and growth and for regulatory compliance, which could have a material adverse impact on the Company’s results of operations, financial condition and cash flows. The Company will also require significant additional funds if it expands the scope of current plans for research and development or if it were to acquire any other assets and advance their development. It is possible that future financing will not be available or, if available, may not be on favorable terms. The availability of financing will be affected by the achievement of the Company’s corporate goals, the results of scientificpreclinical and clinical research, the need and ability to obtain regulatory approvals and the state of the capital markets generally. If adequate funding is not available, the Company may be required to delay, reduce or eliminate one or more of its research and development programs, or obtain funds through corporate partners or others who may require the Company to relinquish significant rights to its psychedelic-inspired drug candidates or obtain funds on less favorable terms than the Company would otherwise accept. To the extent that external sources of capital become limited or unavailable or available on onerous terms, the Company’s intangible assets and its ability to continue its business plans may become impaired, and the Company’s assets, liabilities, business, financial condition and results of operations may be materially or adversely affected.

Reworded

We may rely on third parties to plan and conduct preclinical studies and clinical trials.

Reworded

We may rely on third parties to conduct preclinical development activities and intend to partner with third parties who may conduct clinical development activities with our psychedelic-inspired drug candidates and other product candidates. Preclinical activities include “in vivo” studies providing access to specific disease models, pharmacology and toxicology studies, and assay development. Clinical development activities include trial design, regulatory submissions, clinical patient recruitment, clinical trial monitoring, clinical data management and analysis, safety monitoring and project management. If there is any dispute or disruption in its relationship with third parties, or if such third parties are unable to provide quality services in a timely manner and at a feasible cost, or if such third parties fail to meet certain development milestones, our active development programs may face delays.

Reworded

For completion of the “in vitro” portion of the preclinical testing we intend to conduct, when only lab-grade and lab-scale drug candidate molecules are required, we intend to synthesize the required psychedelicpsychedelic-related molecules in our laboratories in Calgary or at other third-party contract research organizations (“CROs”) that provide synthetic chemistry services. We have limited control over over these third-party CROs. When larger quantities and higher quality psychedelicpsychedelic-related molecules are required (e.g., for in vivo animal modeltoxicology testingstudies), we intend to contract with appropriate third-party contract manufacturing organizations (“CMOs”), over which we may have limited control to, among other things, supply the active pharmaceutical ingredient (“API”) used inof our drug candidates. We also intend to rely on CMOs to supply APIs and formulated drug products in compliance with GMPCGMP regulations.regulations in a phase-appropriate.

Reworded

All applicable jurisdictions, including Health Canada, and the FDA, ensure the quality of drug candidates by carefully monitoring drug manufacturers’ compliance compliance with GMPCGMP regulations. The GMPCGMP regulations for drug candidates contain minimum requirements for the methods, facilities and controls controls used in manufacturing, processing and packing of APIs and formulated a drug products. There can be no assurances that CMOs will be able to meet our timetable and requirements or carry out their contractual obligations in accordance with the applicable regulations. In addition, the API and/or formulated drug product that they supply to us may not meet our specifications and quality policies and procedures or they may not be able to supply the API and/or formulated drug product in commercial quantities. If we are unable to arrange for alternative third-party supply sources on commercially reasonable terms or in a timely manner, it may delay the development of our drug candidates and could have a material adverse effect on our business operations and financial condition.

Reworded

Further, the failure of CMOs to operate in compliance with GMPCGMP regulations could result in, among other things, certain product liability claims in the event such failure to comply results in defective products (containing our drug candidates) that caused injury or harm. In general, our dependence upon third parties for the supply of our APIs and formulated drug products may adversely affect profit margins and our ability to develop and deliver viable drug candidates on a timely and competitive basis.

Reworded

Our business is highly dependent on key licenses and agreements which expire in a short time period. Specifically, in conducting research and preclinical studies on psychedelic or psychedelic-inspired compounds in compliance with current legislation, we substantially rely on the Facchini Drug License, which expiresexpired on on December 31, 2025. The license has been submitted for renewal and is still pending. Health Canada renews drug licenses annually and Dr. Facchini has held the Facchini Drug License since October 5, 1995 and it has been renewed each year without issue. Dr. Facchini submitted an application for renewal of his Drug License, but as of the date of this Annual Report, he has not yet to receive confirmation of renewal. Until Enveric obtains its own Dealer’s License or Section 56 Exemption necessary for its business, the termination, non-renewal or hindrance of use of the Facchini Drug License would have a material adverse effect on Enveric’s ability to develop psychedelic-inspired drug candidate,candidates, conduct research or operate its business as it currently does. This could have a material adverse impact on Enveric’s financial condition.

Reworded

Before we or third parties (who may license or acquire our drug candidates) are able to obtain marketing approval from regulatory authorities for the sale of products containing our drug candidates, the completion of preclinical studies in animals and extensive clinical trials in humans to demonstrate the safety and efficacy of the drug candidates will be required. Clinical testing is expensive and difficult to design and implement, can take many years to complete and has uncertain outcomes. The outcome of preclinical studies and early clinical trials may not predict the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical, NHP and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety profiles, notwithstanding promising results in earlier trials. We do not know whether the clinical trials that we or third parties may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any products containing our drug candidates in any jurisdiction. A product/compound candidate may fail for safety or efficacy reasons at any stage of the testing process. A major risk we face is the possibility that none of the products containing our drug candidates will successfully gain market approval from Health Canada, the FDA or other regulatory authorities, resulting in our inability to derive any royalty-based revenue from them.

Reworded

Raw Use of raw materials requiringrequires regulatory approval

Reworded

We have never been profitable and we do not expect to be profitable in the foreseeable future. Neither us, nor any third-party partner, have submitted any products containing our products for approval by regulatory authorities in Canada, the United States or elsewhere. As of December 31, 2024,2025, we had an accumulated deficit of $106.1$114.8 million and accumulated other comprehensive losses of $0.6 million. To date, we have devoted most of our financial resources to research and development, including drug discovery research, preclinical development activities, patent application filings and prosecution, and media relation efforts, as well as corporate overhead.

Reworded

Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the FDA, Health CanadaFDA or other regulatory authorities in foreign jurisdictions to perform preclinical studies or clinical trials in addition to those currently expected, or if there are any delays in completing our preclinical studies or the development of any of our drug candidates or other products.candidates. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.

Reworded

We have no commercial licensing, marketing or distribution experience. To develop commercial licensing, distribution and marketing capabilities, we will have to invest significant amounts of financial and management resources, some of which will need to be committed prior to any confirmation that our drug candidates will be approved by the FDA, Health CanadaFDA or other regulatory authorities in foreign jurisdictions. Where we decide to perform commercial licensing, marketing and distribution functions itself or through third parties, we could face a number of additional risks, including that we or our third-party collaborators may not be able to build and maintain an effective marketing or sales force. If we use third parties to market and distribute any products arising from our drug candidates, we may have limited or no control over our commercial licensing, marketing and distribution activities on which our future revenues may depend.

Reworded

Our business is subject to a number of risks and hazards generally, including adverse preclinical trialstudy results, accidents, labor disputes and changes in the regulatory environment. Such occurrences could result in damage to assets, personal injury or death, environmental damage, delays in operations, monetary losses and possible legal liability.

Reworded

We operate our business in a relatively new industry and market. The use of psychedelic-inspired medicines for medicinal purposes has shown promise in various studies and we believe that both regulators and the public have an increasing awareness and acceptance of this promising field. Nevertheless, psychedelics remain a controlled substance in the United States, Canada, and most other jurisdictions and their use for research and therapeutic purposes remains highly regulated and narrow in scope. There is no assurance that the industry and market will continue to grow as currently estimated or anticipated or function and evolve in the manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects the psychedelic manufacturing and medicines industry and market could have a material adverse effect on our business, financial condition and results of operations. We have committed and expect to continue committing significant resources and capital to the development of psychedelic-inspired products for therapeutic uses. As a category of products, medical-grade psychedelics raw materials and psychedelic-derived APIs, and research into such substances, represent relatively untested offerings in the marketplace, and we cannot provide assurance that psychedelics as a category, or that our prospective psychedelic-inspired products, product candidates, in particular, will achieve market acceptance. Moreover, as a relatively new industry, there are not many established players in the psychedelic-inspired medicines industry whose business model we can emulate. Similarly, there is little information about comparable companies available for potential investors to review in making a decision about whether to invest in our common shares.stock.

Reworded

Therapies containing controlled substances may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval of, and increased expenses for any future therapeutic candidates we may develop. Opponents of these therapies may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort to persuade the medical community to reject these therapies. For example, we may face media-communicated criticism directed at our clinical development program. Adverse publicity from psilocybinthe misuse of psilocybin, a psychedelic may adversely affect the commercial success or market penetration achievable by our product candidates. Anti-psychedelic protests have historically occurred and may occur in the future and generate media coverage. Political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict the introduction and marketing of any future therapeutic candidates.

Reworded

Research in the United States and internationally regarding the medical benefits, viability, safety, efficacy, addictiveness, dosing and social acceptance of psychedelic-inspired products remains in early stages. There have been relatively few clinical trials on the benefits of such products. Although we believe that the articles, reports and studies support our beliefs regarding the medical benefits, viability, safety, efficacy, dosing and social acceptance of psychedelic-inspired products, future research and clinical trials may prove such statements to be incorrect, or could raise concerns regarding, and perceptions relating to, psychedelic-inspired products. Given these risks, uncertainties and assumptions, readers readers should not place undue reliance on such articles and reports. Future research studies and clinical trials may draw opposing conclusions to those stated in this Annual Report or reach negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing, social acceptance or other facts and perceptions related to psychedelic-inspired products, which could have a material adverse effect on the demand for our drug candidates with the potential to lead to a material adverse effect on the Company’s business, financial condition and results of operations.

Reworded

Our operations are subject to various laws, regulations and guidelines relating to, among other things, drug research, development, marketing practices, health and safety, the conduct of operations and preclinical and clinical trials. In addition to FDA or Health Canada restrictions on the marketing marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in in the pharmaceutical and medical industries in recent years, as well as consulting or other service agreements with physicians or other potential referral sources. While to the knowledge of management, we are currently in compliance with all such laws, changes to applicable laws, regulations and guidelines may cause adverse effects to its operations. The risks to the business of the Company represented by this or similar risks are that they could significantly reduce the addressable market for our psychedelic-inspired drug candidates and could materially and adversely affect the business, financial condition and results of our operations.

Reworded

Our current and prospective product candidates, and the development thereof, are or will be subject to the various federal and state laws and regulations relating to the safety and efficacy of health products, such as drugsprescription and medical devices.drugs.

Reworded

We are in the process of developing investigational new drugs for which we intend to pursue FDA approval via the NDA process. In these product candidates and synthetic molecules based on psychedelics, such as psilocybin, mescaline and MDMA, will be the active pharmaceutical ingredients.APIs.

Reworded

In connection with our development and future commercialization (if applicable) of our prospective products, we, and each contemplated product drug candidate, are subject to the Federal Food Drug FDCA and Cosmeticits Actimplementing (FDCA).regulations. The FDCA isdefines intended to assure the consumer, in part, that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and the U.S. Food and Drug Administration (FDA) regulations define the terma “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The definition also includes components of drugs, such as active pharmaceutical ingredients. To be lawfully marketed in the United States, drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.process. If the FDA does not awardgrant premarket approval for our product drug candidates through the NDA process, this will have a material adverse effect on our business, financial condition and results of operations.

Reworded

There is no guarantee that any of our investigational drugs will ever be approved as medicines in any jurisdiction in which the Company operates, as there are currently very few FDA-approved drugs containing the psychedelic ingredients we intend to utilize as active ingredients. And, Moreover, the laws and regulations generally applicable to the industry in which the Company is involved are subject to constant evolution and may change in ways currently unforeseen. Any amendment to or replacement of existing laws or regulations, including the re-classification of the substances the Company is developing or with which it is working, which are matters beyond the Company’s control, may cause the Company’s business, financial condition, results of operations and prospects to be adversely affected or may cause the Company to incur significant costs in complying with such changes or it may be unable to comply therewith. A violation of any applicable laws and regulations of the jurisdictions in which the Company operates could result in significant fines, penalties, administrative sanctions, convictions or settlements arising from civil proceedings initiated by either government entities in the jurisdictions in which the Company operates, or private citizens or criminal charges.

Reworded

We are in the process of developing investigational new drugs for which we intend to pursue FDA approval via the NDA process. In connection with our development and future commercialization (if applicable) of our products, we and each contemplated product candidate are subject to the Federal Food Drug and Cosmetic Act (FDCA).FDCA. The FDCA is intended to assure the consumer, in part, that drugs and devices are safedefines and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and FDA regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), that is claimed to be beneficial for such uses will be regulated by FDA as a drug. The definition also includes components of drugs, such as active pharmaceutical ingredients. Drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.process. If the FDA does not awardgrant premarket approval for our product drug candidates through the NDA process, this could have a material adverse effect on our business, financial condition and results of operations.

Reworded

We currently have one drug candidate that is in preclinical development forwith potential future indications such as depression and anxiety. We intend to develop additional additional drug candidates targeting other indications, including, for example, addiction and PTSD. After completing the requisite preclinical testing, testing, submissions to the FDA (namelynamely, IND applications), internal review board (“IRB”) review, and any other applicable obligations obligations that must be completed before clinical testing may begin in the United States, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive, time consuming, and uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, or at all. Failures in connection with one or more clinical trials can occur at any stage of testing.

Reworded

The FDA and other applicable regulatory agencies may analyze or interpret the results of clinical trials differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our productdrug candidates are expected to continue for several years and may take significantly longer to complete. Events that may prevent successful or timely completion of clinical development include (without limitation):

Reworded

If we are unable to locate and enroll a sufficient number of eligible patientssubjects to participate in our clinical trials for our productdrug candidates as required by the FDA or similar regulatory authorities outside the United States,U.S., we may not be able to initiate or conduct our trials. Our inability to enroll a sufficient number of patientssubjects for our trials would result in significant delays and could require us to postpone or abandon clinical trials. Enrollment delays may result in increased development costs for our productdrug candidates.

Reworded

We are subject to extensive regulation by U.S. federal and state and foreign governments in each of the U.S., European and Canadian markets, in which we plan to sell market our productdrug candidates. We must adhere to all regulatory requirements, including FDA’s Good Laboratory Practice (“GLP”), GCP, and GMPCGMP requirements, pharmacovigilance requirements, advertising and promotion restrictions, reporting and recordkeeping requirements, and their European equivalents. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval requirements, then the FDA or other foreign regulatory authorities could sanction our Company. Even if a drug is approved by the FDA or other competent authorities, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costlyfinancially burdensome post-marketing trials.

Reworded

Any of our productdrug candidates which may be approved in the U.S. will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP.the CGMPs. As such, we and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic inspections to assess compliance with GMP.the CGMPs. Accordingly, we and others with whom we work will have to spendexpend time, money and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Similar restrictions and requirements exist in the European Union and other markets where we operate.

Reworded

If we successfully complete the requisite preclinical and clinical testing, make the required regulatory submissions and obtain any corresponding authorizations or licenses (as applicable), fulfill all other applicable development-related regulatory obligations, and, eventually, obtain FDA approval to market one or more of our current or future product candidates in the United States,U.S., we may be subject to certain healthcare laws and regulations. In both the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our future product candidates. If we are found to be in violation of any of these laws or any other federal, state or foreign regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased uncertainty and risk that we may be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we are ultimately successful in our defense, will cause us to incur significant legal expenses and divert our management’s attention away from the operation of our business. In addition, in many foreign countries, particularly particularly the countries of the European Union, the pricing of prescription drugs is subject to government control.

Reworded

We currently have no products on the market. None of our prospective products or investigational candidates have ever been tested in a human subject. Our ability to achieve and sustain profitability with respect to our product candidates depends on obtaining regulatory approvals for and, if approved, successfully commercializing our product candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our product candidates, we or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety, purity and potency of our product candidates.

Reworded

Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA or other regulatory authorities may disagree with our interpretation of the data. In the event that we obtain negative results from clinical trials for product drug candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and our future product candidates candidates are not approved, we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current business plan may be materially impaired, and our reputation in the industry and in the investment community might be significantly damaged. In addition, our inability to properly design, commence and complete clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.

Reworded

The testing, marketing and manufacturing of any new drug product for use in the UnitedU.S. States will requirerequires approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical and clinical trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed drug candidate and failure to receive such approvals would have an adverse effect on the drug’s potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such proposeddrug drugcandidate from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the United StatesU.S. that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.

Reworded

Additionally, in light of the recent budget and staffing cuts at the FDA, the FDA may experience delays reviewing or approving our prospective products or current or future productdrug candidates, which could impair our ability to commercialize our prospective products or current or future product candidates and have a material adverse effect on the business, financial condition and operating results of the Company.

Reworded

After completing preclinical testing and obtaining the requisite regulatory authorizations, as applicable, we may voluntarily suspend or terminate our clinical trials for any number of reasons, including if we believe that a product’s use, or a person’s exposure to it, may cause adverse health consequences or death. In addition, regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB or data safety monitoring board to temporarily or permanently discontinue a clinical trial, if we elect or are forced to suspend or terminate a clinical trial of any of our future product drug candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events may result in labeling statementsfor such ascertain warnings or contraindications.contraindications that may negatively affect commercialization.

Reworded

Successful execution of our strategy is contingent, in part, upon compliance with regulatory requirements from time to time enacted by governmental authorities and obtaining all regulatory approvals, where necessary, for the development of our psychedelic-inspired drug candidates. The abuse liability potential of our psychedelic-inspired drug candidates has not yet been studied in preclinical or clinical studies. Therefore, Health Canada or the FDA have not yet determined whether our psychedelic-inspired drug candidates will be scheduled as controlled substances. Based on the studies Health Canada or the FDA or other regulatory authorities may determine that our psychedelic-inspired drug candidates are controlled substances andand, therefore, would require classification as a controlled substance with all the requisite controls.

Reworded

Further, we may not be able tocannot predict the time required to secure all appropriate regulatory approvals for our psychedelic-inspired drug candidates, or the extent of testing and documentation that may, from time to time, be required by governmental authorities. The impact of compliance regimes, any delays in obtaining, or failure to obtain regulatory approvals may significantly delay or impact the development of markets, our business and psychedelic-inspired drug candidates, and licensing initiatives and could have a material adverse effect on the business, financial condition and operating results of the Company.

Reworded

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act as well as rules implemented by the SEC and Nasdaq,the Nasdaq Stock Market LLC (“Nasdaq”), impose various requirements on public companies, including those related to corporate governance practices. Our Our management and other personnel must devote a substantial amount of time to these requirements. Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time consuming and costly.

Reworded

Our management performed an assessment of the Company’s significant processes and key controls. Based on this assessment, management concluded that our internal control over financial reporting was not effective as of December 31, 2024 and December 31, 20232025, due to the material weakness related to segregation of duties. As of December 31, 2024 and December 31, 2023,2025, there were control deficiencies which constituted a material weakness in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

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New heading “Registered Direct Offering and Concurrent Private Placement”

New heading “December 2025 Inducement Warrant Transaction”

New heading “Nasdaq Compliance on Minimum Bid Price Deficiency”

New heading “October 2025 Reverse Stock Split”

New heading “Nasdaq Compliance on Stockholders’ Equity Deficiency”

New heading “September 2025 Inducement Warrant Transaction”

New heading “January 2025 Public Offering”

Removed heading “Neuroplastogens”

Removed heading “Reverse Stock Split”

Removed heading “Nasdaq Bid Price Deficiency”

Removed heading “License Agreement with MycoMedica Life Sciences”

Removed heading “License Agreement with Aries Science and Technology”

Removed heading “Equity Distribution Agreement”

Removed heading “Lincoln Park Equity Line”

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Removed heading “Change in Fair Value of Investment Option Liability”

Removed heading “Inducement Expense”

Removed heading “Change in Fair Value of Derivative Liability”

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“On May 16, 2024, the Company received a letter from Nasdaq notifying the Company that for the prior 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (“Bid Price Rule”). The deficiency letter did not result in the immediate delisting of the Company’s common stock from Nasdaq. …”
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Removed text topics: going concern
“As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.”
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“Registered Direct Offering and Concurrent Private Placement”
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“Nasdaq Compliance on Stockholders’ Equity Deficiency”
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“License Agreement with Aries Science and Technology”
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“Change in Fair Value of Investment Option Liability”
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Reworded

References to the “Company,Company”, “Enveric,” “our,” “us,” or “we” in this section titled “Management’s Discussion Discussion and Analysis of Financial Condition and Results of Operations of Enveric” refer to Enveric Biosciences, Inc. The following discussion discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K.Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K,Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements involving risks and uncertainties and should be read together with the “Risk Factors” and the “Cautionary Statement Regarding Forward-Looking Statements” sections of this Annual Report on Form 10-K.Report. Such risks and uncertainties could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Added

We are a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of patent protected chemical structures, we are advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Our lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT2A and 5-HT1B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

Added

Our lead program, the EVM301 Series, and our lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. EB-003 is a novel derivative of DMT. It is currently advancing through preclinical studies with the aim of initiating first-in-human studies to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders.

Added

We intend to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research. We plan to submit filings including IND applications and, eventually, NDAs to seek approval with the FDA and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates. The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval and finalization of commercial plans. Our EB-003 program has completed short-term dose-range finding toxicology studies and is now ready to advance into IND-enabling, GLP compliant safety pharmacology, ADMET and longer-term toxicology studies.

Added

We unveiled the EVM401 Series on February 25, 2025, which is intended to broaden its pipeline with additional non-hallucinogenic molecules and strengthen our ability to target addiction and neuropsychiatric disorders for patients with limited options. While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series.

Removed

We are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, addiction, and other psychiatric disorders. Leveraging our unique discovery and development platform, the Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates.

Removed

Enveric’s lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. Enveric unveiled its EVM401 Series on February 25, 2025, which is intended to broaden Enveric’s pipeline with additional non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited options. Previously, Enveric was developing the EVM201 Series, and its drug candidate EB-002 (formerly EB-373), for the treatment of neuropsychiatric disorders. The EVM201 Series comprised next generation synthetic prodrugs of the active metabolite, psilocin. Recently, Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize EB-002, in exchange for certain development and milestone payments to Enveric (discussed below).

Removed

Neuroplastogens

Removed

Following our amalgamation with MagicMed in September 2021, we have continued to pursue the development of MagicMed’s proprietary library, the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including depression, anxiety, and addiction disorders. We synthesize novel phenylalkylamines and indolethylamines, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 20 patent families with claims covering a million potential molecular structures, over one thousand of which we have so far synthesized in sufficient quantities to identify and hundreds of which we have screened for receptor binding and other relevant activities.

Removed

The Company developed certain intellectual property rights around the trademark PsyAI™ for potential use. On March 6, 2025, Enveric announced it is soliciting Requests-For Proposals (“RFPs”) for the license or sale of its PsyAI™ trademark portfolio as a means of maximizing value for an asset which is no longer strategic given the Company’s focus on drug development. This limited portfolio of US and Canadian trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc. Enveric expects the period for RFPs to remain open until August 31, 2025, with a decision to follow within three (3) months thereafter.

Removed

At this stage, we have entered into several non-binding term sheets with strategic partners to out-license certain molecules from the Psybrary™. Going forward, in order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions. The in-licensed assets could include both research stage and clinical stage drug candidates.

Removed

While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of the product is shown in the table below:

Removed

Reverse Stock Split

Removed

We effected a 1-for-15 reverse stock split on January 27, 2025, which began trading on a split-adjusted basis on January 29, 2025, pursuant to which every 15 shares of our issued and outstanding common stock were reclassified as one share of common stock. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that were to otherwise have resulted from the reverse stock split were rounded up to the next whole number. The reverse stock split had no impact on the par value of our common stock or the authorized number of shares of our common stock.

Removed

Nasdaq Bid Price Deficiency

Removed

On May 16, 2024, the Company received a letter from Nasdaq notifying the Company that for the prior 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (“Bid Price Rule”). The deficiency letter did not result in the immediate delisting of the Company’s common stock from Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, until November 12, 2024, to regain compliance with the Bid Price Rule. On November 20, 2024, Nasdaq issued a delisting notice, indicating that the Company did not satisfy the Bid Price Rule by the compliance date and that unless the Company requested an appeal of this determination before Nasdaq’s listing qualifications panel, our common stock would be scheduled for delisting from Nasdaq and trading suspended. We appealed the determination before Nasdaq’s listing qualifications panel and on December 30, 2024, the Company received an extension until May 19, 2025, to regain compliance with Bid Price Rule. On March 4, 2025, the Company received notice from the Nasdaq Office of General Counsel that the Company regained compliance with the Bid Price Rule.

Removed

License Agreement with MycoMedica Life Sciences

Removed

On November 7, 2024, Enveric executed a licensing agreement with MycoMedica Life Sciences, PBC (“MycoMedica”), out-licensing the Company’s EVM201 program, including drug candidate EB-002. Pursuant to the terms of licensing agreement, MycoMedica will seek to develop, manufacture, and commercialize EB-002, formerly EB-373, a synthetic prodrug of the active metabolite psilocin, for the treatment of neuropsychiatric disorders such as depression. MycoMedica received an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound. MycoMedica assumed the responsibility for all future preclinical, clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications. As part of the license agreement, Enveric received a modest upfront payment of $20,000 (recorded as other income), and if certain conditions are met, will receive development and sales milestones potentially totaling up to $62 million, plus tiered single digit royalties on all future sales. MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending upon the stage of product development and commercialization at the time of the buyout. Further, MycoMedica has the right to purchase the licensed patents at a nominal amount upon a change of control of Enveric, although doing so does not relieve MycoMedica of any of its payment obligations. No royalties have been received to date.

Removed

License Agreement with Aries Science and Technology

Removed

On July 10, 2024, Akos Biosciences, Inc., a Delaware corporation (“Akos”), wholly-owned subsidiary of Enveric, entered into an exclusive license agreement with Aries Science and Technology, LLC (“Aries”) pursuant to which Akos granted Aries a license of Akos’s patented radiation dermatitis topical product. The license allows Aries to use the patented formulation to develop pharmaceutical or non-pharmaceutical products for treating radiation dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain exceptions contained in the Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties on future sales, if all conditions are met. Aries has the option during the license term, to purchase the rights to each licensed product (on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable licensed product), fully paid, transferable right and license to the licensed product. No royalties have been received to date.

Removed

Equity Distribution Agreement

Removed

On September 1, 2023, the Company entered into a Distribution Agreement (“Distribution Agreement”), with Canaccord Genuity, LLC (“Canaccord”), pursuant to which the Company may offer and sell from time to time, through Canaccord as sales agent and/or principal, shares of common stock of the Company having an aggregate offering price of up to $10.0 million. Due to the offering limitations applicable to the Company and in accordance with the terms of the Distribution Agreement, the Company may offer common stock having an aggregate gross sales price of up to $2,392,514 pursuant to the prospectus supplement dated September 1, 2023. Subject to the terms and conditions of the Distribution Agreement, Canaccord may sell the common stock by any method permitted by law deemed to be an “at-the-market offering”. The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the common stock sold through Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses. The Company may also sell common stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale. Any sale of common stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.

Removed

During the year ended December 31, 2024, the Company issued 111,200 shares of common stock for gross proceeds of $2,392,502 under the Distribution Agreement, and charged offering costs of $583,713 to additional paid in capital on the consolidated balance sheet. As of December 31, 2024 and 2023, there were deferred offering costs related to the Distribution Agreement of $0 and $171,944, respectively. The Company does not anticipate issuing further securities pursuant to the Distribution Agreement.

Removed

Lincoln Park Equity Line

Removed

On November 3, 2023, the Company entered into a Purchase Agreement (the “Lincoln Park Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock subject to certain limitations and satisfaction of the conditions set forth in the Lincoln Park Purchase Agreement.

Removed

Under the terms and subject to the conditions of the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase Shares”). However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the Lincoln Park Purchase Agreement, including limitations on number of shares that may be sold. Sales may occur from time to time, at the Company’s sole discretion, over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Lincoln Park Purchase Agreement are satisfied, including that a registration statement on Form S-1 covering the resale of the shares of the Company’s Common Stock that have been and may be issued to Lincoln Park under the Lincoln Park Purchase Agreement, which the Company has filed with the SEC pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC. As required under the Lincoln Park Purchase Agreement, the Company registered a resale of 76,032 shares of our common stock, plus the 9,294 commitment shares, by Lincoln Park on a registration statement on Form S-1 dated November 8, 2023, which was declared effective by the SEC on December 5, 2023. As of July 30, 2024, there were no remaining shares available to be issued in connection with this registration statement. On September 4, 2024, the Company filed a new registration statement on Form S-1, which was declared effective by the SEC on September 11, 2024. The new Form S-1 registered an additional 326,667 shares of common stock that are available to be issued to Lincoln Park in connection with the Lincoln Park Purchase Agreement. During the year ended December 31, 2024, the Company had issued 159,366 shares of common stock, through the Lincoln Park Purchase Agreement for gross cash proceeds of $1,083,709. As of December 31, 2024 there were 243,334 remaining shares available to be issued in connection with this amended registration statement. The Company engaged in a best efforts public offering in the first quarter of 2025 (described below), which restricts the use of the Lincoln Park Equity Line for a period of one year from February 3, 2025.

Removed

Because the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that the Company may elect to sell to Lincoln Park under the Lincoln Park Purchase Agreement, if any, will fluctuate based on the market prices of the Company’s Common Stock at the time the Company elects to sell shares to Lincoln Park pursuant to the Lincoln Park Purchase Agreement, if any, it is not possible for us to predict the number of shares of Common Stock that the Company will sell to Lincoln Park the purchase price per share that Lincoln Park will pay for shares purchased from us or the aggregate gross proceeds that the Company will receive from those purchases by Lincoln Park.

Removed

Registered Direct Offerings

Removed

Between March and May 2024, the Company entered into a series of common stock purchase agreements (the “Purchase Agreements”) for the issuance in a registered direct offering of an aggregate of 45,780 shares of the Company’s common stock to certain institutional investors. The issuance was made in exchange for the permanent and irrevocable waiver of the variable rate transaction limitation contained in certain inducement offer letters, dated December 28, 2023, between the Company and the institutional investors with respect to any existing or future agreement by the Company to effect any issuance of shares. The Company did not receive any net proceeds in connection with the offering. The offering was made to obtain a waiver of the variable rate transaction limitation as described above and further described in the Purchase Agreements so the Company could utilize its equity line of credit with Lincoln Park, and enter into any future agreements that involve a variable rate transaction and issue such shares thereunder. The fair value of the shares issued for consideration of waiving the variable rate transaction limitation was $322,453 and was charged to additional paid in capital, as it is direct and incremental to the Distribution Agreement, on the unaudited condensed consolidated balance sheet as an offering cost related to the Distribution Agreement. The fair value of the shares issued for consideration of waiving the variable rate transaction limitation was $448,840 and was recorded as deferred offering costs, as direct and incremental to the Purchase Agreement, within prepaid expenses and other current assets on the unaudited condensed consolidated balance sheet related to the Purchase Agreement.

Reworded

January 2025At the Market Offering

Added

On April 9, 2025, we entered into an At the Market Offering Agreement (“ATM Agreement”), with H.C. Wainwright & Co., LLC, acting as sales agent. As of December 31, 2025, we had issued 110,242 shares under the ATM Agreement for net cash proceeds of $1,636,799. On February 6, 2026, we filed a prospectus supplement so that we may additionally issue and sell our common stock having an aggregate sales proceeds of up to $1,346,000 from time to time pursuant to the ATM Agreement. On February 19, 2026, the Company issued 497,200 shares of our common stock for net cash proceeds of $1,303,415.

Added

Registered Direct Offering and Concurrent Private Placement

Added

On January 27, 2026, we entered into a securities purchase agreement with certain institutional investors, pursuant to which we agreed to issue and sell to the investors in a registered direct offering (the “Registered Direct Offering”), an aggregate of 328,802 shares (the “RD Shares”) of our common stock at a price of $4.41 per share for gross proceeds of approximately $1.5 million before the deduction of placement agent fees and offering expenses. The closing of the Registered Direct Offering occurred on January 28, 2026.

Added

In the concurrent private placement we also agreed to issue and sell to the Investors the Series G Warrants to purchase up to an aggregate of 328,802 shares of common stock and the Series H Warrants purchase up to an aggregate of 328,802 shares of common stock, each at an exercise price of $4.16 per share.

Added

We issued H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase up to 23,016 shares of common stock with an exercise price of $5.5125 per share. We also incurred legal and other offering-related fees in connection with this offering.

Added

December 2025 Inducement Warrant Transaction

Added

On December 11, 2025, we entered into warrant exercise inducement offer letters (the “December Inducement Letters”) with certain institutional investors that held certain outstanding warrants to purchase up to an aggregate of 426,390 shares originally issued in February 2025 and September 2025, having exercise prices of $36.00 and $10.98 per share, respectively (collectively, the “December Existing Warrants”).

Added

Pursuant to the December Inducement Letters, the investors agreed to exercise for cash their December Existing Warrants at a reduced exercise price of $7.05 per share and pay a purchase price of $0.125 per share in consideration for our agreement to issue in a private placement (x) new Series E Common Stock Purchase Warrants to purchase up to 426,390 shares of common stock and (y) new Series F Common Stock Purchase Warrants to purchase up to 426,390 shares of common stock. We received aggregate gross proceeds of approximately $3.1 million from the exercise of the December Existing Warrants by the investors and payment of the purchase price of $0.125 per share, before deducting placement agent fees and other offering expenses payable by us. The closing of the transactions occurred on December 12, 2025.

Added

We issued H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase up to 29,847 shares of common stock with an exercise price of $9.125 per share. We also incurred legal and other offering-related fees in connection with this warrant inducement transaction.

Added

Nasdaq Compliance on Minimum Bid Price Deficiency

Added

By way of background, on October 22, 2025, we received written notice from the Listing Qualifications Department of Nasdaq notifying the Company that, because the closing price of our common stock had fallen below $1.00 per share for 30 consecutive trading days, we were no longer in compliance with the requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). On November 12, 2025, we received a letter from the Nasdaq Listing Qualifications Department of Nasdaq notifying us that we regained compliance with the minimum bid price requirement set forth in in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.

Added

October 2025 Reverse Stock Split

Added

On October 23, 2025, we effected a 1-for-12 reverse stock split (the “October 2025 Reverse Stock Split”), which began trading on a split-adjusted basis on October 28, 2025, pursuant to which every 12 shares of our issued and outstanding shares of common stock were reclassified as one share of common stock. The October 2025 Reverse Stock Split had no impact on the par value of our common stock or the authorized number of shares of common stock. Unless otherwise indicated, all share and per share information prior to the October 2025 Reverse Stock Split date of October 28, 2025 in this Annual Report are retroactively adjusted to reflect the October 2025 Reverse Stock Split.

Added

Nasdaq Compliance on Stockholders’ Equity Deficiency

Added

On October 23, 2025, we notified Nasdaq that we believed we had regained compliance with the stockholders’ equity requirements set forth in Nasdaq Listing Rule 5550(b)(1) for continued listing on The Nasdaq Capital Market. On October 24, 2025, we received a letter from Nasdaq determining that we regained conditional compliance subject to evidencing compliance upon filing our next periodic report. As detailed in our Quarterly Report for the quarter ended September 30, 2025, filed with the SEC on November 14, 2025, we reported stockholders’ equity in excess of the required $2.5 million and, as a result, regained compliance with the stockholders’ equity requirement. On August 26, 2025, we had received a deficiency letter from the Listing Qualifications Department of Nasdaq notifying the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1).

Added

September 2025 Inducement Warrant Transaction

Added

On September 17, 2025, we entered into warrant exercise inducement offer letters (the “September Inducement Letters”) with certain holders of our Series A Warrants and Series B Warrants originally issued in February 2025 (the “September Existing Warrants”), which closed on September 18, 2025. Pursuant to the September Inducement Letters, the holders agreed to exercise for cash their September Existing Warrants to purchase 202,083 shares of our common sock, in the aggregate, at a reduced exercise price of $10.98 per share (from an original exercise price of $36.00 per share), in exchange for our agreement to issue new warrants Series C Warrants and Series D Warrants to purchase up to 404,166 shares of the our common stock under each series, each at an exercise price of $10.98 per share.

Added

We received aggregate gross proceeds of $2,218,873 from the exercise of the Existing Warrants. We issued H.C. Wainwright & Co., LLC, as placement agent warrants to purchase up to 14,146 shares of common stock with an exercise price of $13.7256 per share. The grant date fair value of these placement agent warrants was estimated to be $90,000 on September 18, 2025 and was charged to additional paid-in capital as issuance costs. We also incurred legal and other offering-related fees of $334,659, which were similarly charged to additional paid-in capital.

Added

January 2025 Public Offering

Reworded

On January 30, 2025, the Companywe commenced a best efforts public offering (the “Public Offering”) of an aggregate of (i) 1,229,330 102,444 shares (the “Shares”) of common stock of the Company,stock, (ii) 437,336 36,444 pre-funded warrants (the “Pre-Funded Warrants”) to purchase 437,33636,444 shares of common stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666138,889 Series A warrants (the “Series A Warrants”) to purchase 1,666,666138,889 shares of common stock (the “Series A Warrant Shares”), stock, and (iv) 1,666,666138,889 Series B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”)warrants to purchase 1,666,666 138,889 shares of common stock. Each share of common stock (the “Series B Warrant Shares”). Each Share or Pre-Fundedpre-funded Warrantwarrant was sold together with one Series A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock. The offering price for each Shareshare and accompanying Series A and Series B Warrants was $3.00,$36.00, and the offering price for each Pre-Funded Warrantre-funded warrant and accompanying Warrantswarrants was $2.9999. $35.9988. The Pre-Fundedpre-funded Warrantswarrants have an exercise price of $0.0001$0.0012 per share, are exercisable immediately and will expire when exercised in full. Each Warrantwarrant has an exercise price of $3.00$36.00 per share and will beare exercisable immediately upon issuance (“Initial Exercise Date”).issuance. The Series A Warrants expire onfive theyears five-yearafter anniversary of the Initial Exercise Date.issuance. The Series B Warrants expire on18-months theafter 18-month anniversary of the Initial Exercise Date.issuance.

Reworded

The Public Offering closed on February 3, 2025. The net proceeds of the Public Offering, after deducting the fees and expenses of the PlacementH.C. AgentWainwright (& Co., LLC, as defined below)placement agent, and other offering expenses payable by the Company,us, but excluding the net proceeds, if any, from the exercise of the Warrants,warrants, iswas approximately $4.2 million. The Company intends to use the net proceeds from the Offering for working capital, EB-003 development, and general corporate purposes.

Reworded

We are a pre-revenue biotech company that has to date, not generated any revenues. During the year ended December 31, 2024,2025, we raised approximately $8.0 $10.5 million from the sales of Commonour Stockcommon stock and warrants.warrants to purchase our common stock. These amounts were the primary source of funds upon which our operations were financed during the year ended December 31, 2024.2025.

Reworded

RSA’s and RSU’s may contain vesting conditions that include, without limitation, any or all of the following: immediate vesting, vesting over a defined time period, vesting based on specific volume weighted average price levels being achieved by the Company’s common stock as publicly traded within specified measurement periods, and vesting based on the achievement of specific performance milestones. RSUs may also contain certain delivery conditions including, without limitation, delivery conditioned on change in control or termination of services for any reason other than for cause. Options contain vesting conditions that provide for vesting over a defined time period.

Reworded

Our general and administrative expenses decreased to $5,792,573 for the year ended December 31, 2025 from $6,453,505 for the year ended December 31, 2024 from $8,852,021 for the year ended December 31, 2023,2024, a decrease of $2,398,516,$660,932, or 27%.10%. This change was primarily driven by decreases in consultinglegal fees of $262,077, director fees of $253,719, stock compensation expense of $215,306, Delaware Franchise Tax expenses of $1,067,245, salaries and wages of $623,101, stock compensation expense of $508,785, accounting fees of $345,488,$133,612, insurance expenses of $193,932,$101,428, and software consulting expenses of $183,681. $70,179. This is offset by an increase in director fees of $223,700, public company fees of $182,643, and Delaware Franchise Taxmarketing expenses of $81,421.$433,654.

Reworded

The decrease in consultinglegal fees was due to decreaseddeferred outsourcingoffering costs that were expensed during the year ended December 31, 2024 related to contractors.the Lincoln Park equity line. The decrease in salariesdirector and wagesfees was primarily due to the reductionmix of cash versus equity compensation, including the issuance of full equity awards in force.2025 rather than cash payments in lieu of shares. The decrease in stock compensation expense was primarily to a reduction in expense related to restricted stock units as a result of forfeitures and decreased value of new grants as a result of lower stock prices. The decrease in accountingDelaware Franchise feesTax expense was primarily due to ahigher reduction expense in technical2024 accountingdue services.to the Company filing an amended 2023 return during 2024. The decrease in insurance expense was due to lower premiums as a result of lower payroll costs. The decrease in softwareconsulting expense was due to decreased outsourcing to contractors. The increase in marketing expenses was due to theincreased down-sizedigital inmarketing operations of Enveric Canada. The increase in director fees was due to the addition of a director to the Board during 2024 and cash payments made to each director during the year. The increase in public company fees was due to an increase in broker fees and other public company filing fees.campaigns.

Added

Our research and development expense for the year ended December 31, 2025 was $2,781,017 as compared to $2,841,272 for the year ended December 31, 2024 with a decrease of $60,255, or approximately 2%. This decrease was primarily driven by decreased salaries and wages of $633,549, CRO costs, net of tax incentives of $205,018, research costs of $380,159, lab expenses of $59,090, product development costs of $33,620, and rent of $28,143. This is offset by an increase in consulting expenses of $1,311,430.

Reworded

Our researchThe and development expense for the year ended December 31, 2024 was $2,841,272 as compared to $7,252,437 for the year ended December 31, 2023 with a decrease of $4,411,165, or approximately 61%. This decrease was primarily driven by decreased salaries and wages of $1,560,017, research costs of $1,346,647, CRO costs of $1,247,284, lab expenses of $158,514, tax incentive of $149,262, and rent of $86,098. The decrease in salaries and wages was due to the reduction in force as a result of the Company’s cost reduction plan. The decrease in researchCRO costs and CROresearch costs was due to the completion of the Australia research and development project during the second quarter of 2024. The decrease in lab expenses and product development costs was due to a reduction in research and development duringthat 2024. The decreasebegan in tax incentives was due to a tax credit received during 2024. The decrease in rent was due to the expiration of the Company’s Canadian lease during 2024. These decreases were slightly offset by an increase in consulting fees of $366,060. The increase in consulting fees was due to certain employees that were hired on a part-time consultant basis to perform certain research and development activities. The increase in tax incentives was due to a tax credit received during 2024.

Reworded

Depreciation and amortization expense for the year ended December 31, 20242025 was $337,489$200,858 as compared to $343,982$337,489 for the year ended December 31, 2023, 2024, with a decrease of $6,493,$136,631, or approximately 2%.40%, primarily related to full amortization of the Company’s intangible assets in the first quarter of 2025.

Removed

Change in Fair Value of Warrant Liabilities

Removed

Change in fair value of warrant liabilities for the year ended December 31, 2024 resulted in income of $24,370 as compared to $94,396 for the year ended December 31, 2023. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock. The significant decrease in the Company’s stock price during the year ended December 31, 2024 compared to the year ended December 31, 2023, resulted in the significant decrease to the change in fair value of warrant liabilities.

Showing the first 60 of 80 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-14 (period ending 2026-06-30) with 10-Q filed 2026-05-15 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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395 → 493words in section

New heading “Our ability to maintain compliance with Nasdaq listing standards may be adversely affected by Nasdaq’s recently approved Market Value of Listed Securities requirement, and any failure to satisfy applicable listing standards could result in the delisting of our Common Stock.”

Removed heading “Trading in our Common Stock may be subject to temporary trading halts due to volatility rules, which could adversely affect stockholders’ ability to buy or sell their shares.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: delist
“Our ability to maintain compliance with Nasdaq listing standards may be adversely affected by Nasdaq’s recently approved Market Value of Listed Securities requirement, and any failure to satisfy applicable listing standards could result in the delisting of our Common Stock.”
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New text topics: delist
“If the new MVLS requirement becomes operative and our MVLS falls below $5 million and remains below that threshold for the applicable measurement period, Nasdaq could issue a Staff Delisting Determination. Under the approved rule, a hearing request generally would not stay the suspension of trading of our Common Stock. As a result, our Common Stock could be suspended from trading on Nasdaq and trade, if at all, on the over-the-counter market while any appeal is pending. …”
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Removed text
“Trading in our Common Stock may be subject to temporary trading halts due to volatility rules, which could adversely affect stockholders’ ability to buy or sell their shares.”
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Removed text topics: securities and exchange commission
“Our Common Stock is listed on The Nasdaq Capital Market (“Nasdaq”). Nasdaq, as well as other U.S. securities exchanges, is subject to rules promulgated by the U.S. Securities and Exchange Commission designed to reduce extraordinary market volatility, including the Limit Up-Limit Down (“LULD”) rules. Under the LULD rules, trading in a listed security may be subject to a temporary pause or halt when the price of that security moves outside of a specified price band within a short period of time.”
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Removed text topics: liquidity
“We have no control over whether Nasdaq or other regulatory bodies impose trading halts on our Common Stock. The occurrence of trading halts, whether due to the LULD rules or otherwise, could adversely affect the liquidity and market price of our Common Stock and could harm our stockholders’ ability to manage their investment in our securities.”
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New text
“In July 2026, the SEC approved a Nasdaq rule change establishing a new continued listing requirement based on a company’s market value of listed securities (“MVLS”). Under the new requirement, companies listed on the Nasdaq Capital Market generally must maintain an MVLS of at least $5 million. …”
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Reworded

Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 27, 2026.2026, as well as the risks and uncertainties described in the Company’s subsequently filed Quarterly Reports on Form 10-Q and other filings with the SEC. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, other than as described below, there have been no material changes to the risk factors disclosed in the Company’s Annual Annual Report.

Added

Our ability to maintain compliance with Nasdaq listing standards may be adversely affected by Nasdaq’s recently approved Market Value of Listed Securities requirement, and any failure to satisfy applicable listing standards could result in the delisting of our Common Stock.

Added

In July 2026, the SEC approved a Nasdaq rule change establishing a new continued listing requirement based on a company’s market value of listed securities (“MVLS”). Under the new requirement, companies listed on the Nasdaq Capital Market generally must maintain an MVLS of at least $5 million. Although the implementation of this requirement is currently stayed, and our MVLS was above the $5 million threshold as of the date of this Quarterly Report, our MVLS has recently been near that threshold and there can be no assurance that we will continue to satisfy the requirement if and when it becomes operative. MVLS is calculated by multiplying the market price of our Common Stock by the number of our outstanding listed shares. The market price of our Common Stock may fluctuate significantly as a result of factors that are beyond our control, including market conditions, investor sentiment, developments relating to our business, clinical, regulatory or financing activities, dilution resulting from future issuances of securities, and broader economic and geopolitical conditions.

Added

If the new MVLS requirement becomes operative and our MVLS falls below $5 million and remains below that threshold for the applicable measurement period, Nasdaq could issue a Staff Delisting Determination. Under the approved rule, a hearing request generally would not stay the suspension of trading of our Common Stock. As a result, our Common Stock could be suspended from trading on Nasdaq and trade, if at all, on the over-the-counter market while any appeal is pending. Although we may have the ability to appeal a Staff Delisting Determination, the authority of the Nasdaq Hearings Panel to grant relief is limited and may require us to demonstrate compliance with Nasdaq’s initial listing standards, which are more stringent than Nasdaq’s continued listing standards and which we may be unable to satisfy.

Removed

Trading in our Common Stock may be subject to temporary trading halts due to volatility rules, which could adversely affect stockholders’ ability to buy or sell their shares.

Removed

Our Common Stock is listed on The Nasdaq Capital Market (“Nasdaq”). Nasdaq, as well as other U.S. securities exchanges, is subject to rules promulgated by the U.S. Securities and Exchange Commission designed to reduce extraordinary market volatility, including the Limit Up-Limit Down (“LULD”) rules. Under the LULD rules, trading in a listed security may be subject to a temporary pause or halt when the price of that security moves outside of a specified price band within a short period of time.

Removed

Our Common Stock has in the past experienced, and may in the future experience, significant price volatility and elevated trading volumes. As a result, trading in our Common Stock has been, and may in the future be, temporarily halted pursuant to the LULD rules or other exchange or regulatory trading halt mechanisms. During any such trading halt, investors will be unable to buy or sell shares of our Common Stock, which could prevent investors from executing trades at desired prices and times. Trading halts may also contribute to uncertainty in the market for our Common Stock and increase price volatility upon the resumption of trading.

Removed

We have no control over whether Nasdaq or other regulatory bodies impose trading halts on our Common Stock. The occurrence of trading halts, whether due to the LULD rules or otherwise, could adversely affect the liquidity and market price of our Common Stock and could harm our stockholders’ ability to manage their investment in our securities.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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2,698 → 3,268words in section

New heading “General and Administrative Expenses”

New heading “Research and Development Expenses”

New heading “Depreciation and Amortization Expense”

Removed heading “Registered Direct and Concurrent Private Placement”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: going concern, labor
“Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, our ability to: finalize and submit its IND filing to the U.S. …”
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New text topics: going concern
“As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the unaudited condensed consolidated financial statements. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.”
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Removed text topics: fine
“In a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “Offerings”), pursuant to the terms of the January 2026 Purchase Agreement, we also agreed to issue and sell unregistered Series G warrants to purchase up to 328,802 shares of Common Stock (the “Series G Warrants”), and unregistered Series H warrants to purchase up to 328,802 shares of Common Stock (the “Series H Warrants”, and collectively with the Series G Warrants, the “Common Warrants”). …”
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“Registered Direct and Concurrent Private Placement”
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New text
“Depreciation and Amortization Expense”
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“General and Administrative Expenses”
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Reworded

The information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc., a Delaware corporation, and its subsidiaries.subsidiaries

Reworded

This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from our historical experience and our present expectations. TheseSpecific risksforward-looking andstatements uncertaintiesin include,this butquarterly arereport include notstatements, limitedamong toothers, regarding:

Added

Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, our ability to: finalize and submit its IND filing to the U.S. Food and Drug Administration; 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.

Reworded

We intend to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research. We plan to submit filings including IND applications and, eventually, NDAs to seek approval with the FDA and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates. The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval and finalization of commercial plans. Our EB-003 program has completed short-term dose-range finding toxicology studies and ishas now ready to advanceadvanced into IND-enabling, GLP compliant safety pharmacology, ADMET and longer-term toxicology studies.

Reworded

In order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions. The in-licensed assets could include both research stage and clinical stage drug candidates. During 2026, a post-grant review petition challenging one of our issued patents was withdrawn. We believe this development further supports the strength of our intellectual property portfolio and our strategy of developing and protecting novel neuroplastogenic compounds.

Added

While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. During the second quarter of 2026, we continued to advance IND-enabling activities for EB-003. In May 2026, we reported positive results from preclinical phototoxicity analyses indicating no photoreactive potential for EB-003. In June 2026, we initiated GLP-compliant genotoxicity studies designed to evaluate the compound’s potential to interact with DNA and cause genetic mutations, which are among the studies required to support a future IND submission. We believe these activities represent important steps in advancing EB-003 toward planned first-in-human clinical studies.

Added

The development status of the product is shown in the table below:

Removed

While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of the product is shown in the table below:

Removed

Registered Direct and Concurrent Private Placement

Removed

On January 27, 2026, we entered into a securities purchase agreement (the “January 2026 Purchase Agreement”) with certain institutional investors (each, an “Investor”), pursuant to which we agreed to issue and sell to the Investors in a registered direct offering, an aggregate of 328,802 shares of Common Stock, at a price of $4.41 per share (the “Registered Direct Offering”) for gross proceeds of approximately $1.5 million before the deduction of placement agent fees and offering expenses. The closing of the Registered Direct Offering occurred on January 28, 2026.

Removed

In a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “Offerings”), pursuant to the terms of the January 2026 Purchase Agreement, we also agreed to issue and sell unregistered Series G warrants to purchase up to 328,802 shares of Common Stock (the “Series G Warrants”), and unregistered Series H warrants to purchase up to 328,802 shares of Common Stock (the “Series H Warrants”, and collectively with the Series G Warrants, the “Common Warrants”). The Common Warrants have an exercise price of $4.16 per share and are exercisable immediately. The Series G Warrants expire five years following the effective date of the Resale Registration Statement (defined below), and the Series H Warrants expire 18 months following the effective date of the Resale Registration Statement. We agreed to file a registration statement providing for the resale of the shares issuable upon the exercise of the Common Warrants and warrants issued to its placement agent within thirty calendar days after the closing date (the “Resale Registration Statement”). We filed the Resale Registration Statement on February 10, 2026, which was declared effective by the SEC on February 17, 2026.

Removed

H.C. Wainwright & Co., LLC (the “Placement Agent”), acted as the exclusive placement agent in connection with the Offerings. We paid the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds of the Offerings as well as a management fee equal to 1.0% of the aggregate gross proceeds of the Offerings. We also paid the Placement Agent $35,000 for accountable expenses, including the Placement Agent’s legal fees and expenses, and $10,000 for a clearing agent fee. We also issued warrants to purchase up to 23,016 shares of Common Stock to the Placement Agent. The placement agent warrants have the same terms as the Series G Warrants, except the placement agent warrants have an exercise price of $5.5125 per share (125% of the offering price).

Reworded

WeOn June 9, 2026, the Company filed a prospectus supplement to increase the registered capacity of its ATM facility by an additional $2,425,000. By way of background, the Company previously entered into an at the market offering agreement,agreement or (the (“ATM Agreement”), with H.C. Wainwright & Co., LLC, acting as sales agent (the “Sales Agent”), on April 9, 2025, relating to shares of Common Stock. Under the ATM Agreement, we may offer and sell shares of Common Stock having an aggregate offering price of up to $1,854,151 from time to time through the Sales Agent. The Sales Agent receives 3% of the gross sales price of the shares sold as a placement fee.

Added

During the six months ended June 30, 2026, the Company issued 497,200 shares for net cash proceeds of $1,291,038.

Removed

On February 6, 2026, the Company filed a prospectus supplement to increase the ATM Agreement’s capacity by an additional $1,346,000, under our existing shelf registration statement. As a result, we issued 497,200 shares on February 19, 2026 for net cash proceeds of $1.3 million.

Reworded

As of MarchJune 31,30, 2026, the Company has issued an aggregate of 607,442 shares under the ATM Agreement, reflecting issuances during both the prior year and the current year, for net cash proceeds of $2,927,837, and $0$2,425,000 remains available to sell.

Added

On April 16, 2026, the Company entered into a securities purchase agreement (the “April 2026 Purchase Agreement”) with certain institutional investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “April Private Placement”) (i) 98,000 shares of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 2,124,223 shares of Common Stock (the “Pre-Funded Warrant Shares”), (iii) Series I warrants to purchase up to 2,222,223 shares of Common Stock (the “Series I Warrants”), and (iv) Series J warrants to purchase up to 2,222,223 shares of Common Stock (the “Series J Warrants,” together with the Series I Warrants, the “April Common Warrants”). In connection with the April Private Placement, the Company entered into a Registration Rights Agreement pursuant to which it agreed to file a registration statement covering the resale of the shares and shares issuable upon exercise of the warrants issued in the April Private Placement (the “Resale Registration Statement”). The Pre-Funded Warrants are immediately exercisable and may be exercised at a nominal exercise price of $0.0001 per share of Common Stock at any time until all of the Pre-Funded Warrants are exercised in full. The April Common Warrants have an exercise price of $2.00 per share and are exercisable immediately. The Series I Warrants expire five years following the effective date of the Resale Registration Statement, and the Series J Warrants expire 18 months following the effective date of the Resale Registration Statement. The aggregate gross proceeds from the April Private Placement were approximately $5.0 million before deducting Placement Agent fees and offering expenses. The closing of the private placement occurred on April 17, 2026.

Added

The Placement Agent acted as the exclusive placement agent in connection with the April Private Placement. The Company agreed to pay the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds of the April Private Placement and a management fee equal to 1.0% of the aggregate gross proceeds of the April Private Placement. The Company also issued warrants to purchase up to 155,556 shares of Common Stock to the Placement Agent. The Placement Agent warrants have substantially the same terms as the Series I Warrants, except the placement agent warrants have an exercise price of $2.8125 per share (125% of the offering price).

Removed

On April 16, 2026, we entered into a securities purchase agreement with certain institutional investors in connection with a private placement, which closed on April 17, 2026. Pursuant to the private placement, we issued shares of our common stock, pre-funded warrants, and warrants to purchase shares of our common stock. The warrants are exercisable immediately and have varying expiration dates. We received gross proceeds of approximately $5.0 million, before deducting placement agent fees, offering expenses, and other costs.

Reworded

The following table sets forth information comparing the components of net loss for the three months ended MarchJune 31,30, 2026 and 2025:

Reworded

Our general and administrative expenses decreasedincreased to $1,249,961$1,635,478 for the three months ended MarchJune 31,30, 2026 from $1,360,138$1,219,018 for the three months ended MarchJune 31,30, 2025, aan decreaseincrease of $110,177,$416,460, or 8%.34%. This change was primarily driven by decreasesincreases in salaries and wages of $11,898,$430,894 filingand Delaware franchise tax fees of $37,023,$50,000, consultingoffset by decreases in legal fees of $36,697,$20,126 audit fees of $19,745,and investor relations of $21,351, stock compensation expense of $19,847, and travel fees of $16,800, partially offset by an increase in marketing expenses of $34,386.$52,798.

Reworded

Our research and development expenseexpenses for the three months ended MarchJune 31,30, 2026 waswere $345,969$1,355,137 as compared to $746,371$1,260,051 for the three months ended MarchJune 31,30, 20252025, withfor aan decreaseincrease of $400,402,$95,086, or approximately 54%.8%. This decreasechange was primarily driven by a decreaseincreases in consulting fees of $187,883, stock compensation expense of $85,328, salaries and wages of $19,486,$108,820, and research costs of $90,642.$52,307, offset by decreases in consulting fees of $65,365.

Reworded

Depreciation and amortization expense for the three months ended MarchJune 31,30, 2026 was $37,240$36,826 as compared to $81,024$39,980 for the three months ended MarchJune 31,30, 2025, with a decrease of $43,784,$3,154, or approximately 54%, primarily8%, due to full amortizationdepreciation of ourcertain intangiblefixed assets induring the first quarter of 2025.2026.

Added

The following table sets forth information comparing the components of net loss for the six months ended June 30, 2026 and 2025:

Added

General and Administrative Expenses

Added

Our general and administrative expenses increased to $2,885,439 for the six months ended June 30, 2026 from $2,579,156 for the six months ended June 30, 2025, an increase of $306,283, or 12%. This change was primarily driven by increases in salaries and wages of $418,996, offset by decreases in consulting fees of $32,051, investor relations of $74,149, and public company fees of $31,703.

Added

Research and Development Expenses

Added

Our research and development expense for the six months ended June 30, 2026 was $1,701,106 as compared to $2,006,422 for the six months ended June 30, 2025, a decrease of $305,316, or approximately 15%. This decrease was primarily driven by a decrease in consulting fees of $253,248 and, research costs of $38,335, offset by an increase in salaries and wages of $4,006.

Added

Depreciation and Amortization Expense

Added

Depreciation and amortization expense for the six months ended June 30, 2026 was $74,066 as compared to $121,004 for the six months ended June 30, 2025, for a decrease of $46,938, or approximately 39%, primarily related to full amortization of our intangible assets in the first quarter of 2025.

Reworded

WeThe haveCompany has incurred losses since inception resulting in an accumulated deficit of $116,479,965$119,507,698 as of MarchJune 31,30, 2026 and further losses are are anticipated in the development of its business. For the threesix months ended MarchJune 31,30, 2026, wethe Company had a loss from operations of $4,660,611. $1,633,170. Further, wethe Company had operating cash outflows of $2,256,839$4,701,378 for the threesix months ended MarchJune 31,30, 2026. Since inception, being a research and development company, wethe haveCompany has not yet generated revenue and havethe Company has incurred continuing losses from its operations. OurThe Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about ourthe Company’s ability to continue as a going concern for a period of one year from the issuance of these unaudited condensed consolidated financial statements.

Reworded

In assessing ourthe Company’s ability to continue as a going concern, wethe monitorCompany monitors and analyzeanalyzes ourits cash and ourits ability to generate sufficient cash flow in the future to support ourits operating and capital expenditure commitments. At June 30, 2026, the Company had cash of $8,296,296 and working capital of $7,931,850. Cash increased to $8,296,296 at June 30, 2026 from $4,908,769 at March 31, 2026, wean increase hadof $3,387,527, or 69%, primarily as a result of proceeds received from the April 2026 private placement and warrant exercises, partially offset by cash ofused $4,908,769in operating activities. Management expects existing cash resources to fund operations only for a limited period and working anticipates the need for additional capital ofto $4,914,423.continue Ourdevelopment activities and satisfy ongoing obligations. As a result, the Company’s current cash on hand is insufficient to satisfy ourits operating cash needs for the 12 months following the filing of of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding ourthe Company’s ability to continue as a going concern concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, sources, and may include additional collaborations with third parties as well as disciplined cash spending. Adequate additional financing may may not be available to us on acceptable terms, or at all. Should wethe Company be unable to raise sufficient additional capital, wethe Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Added

As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the unaudited condensed consolidated financial statements. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Reworded

Cash Flows for the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

Removed

Net cash used in operating activities was $2,256,839 during the three months ended March 31, 2026, which consisted primarily of a net loss adjusted for non-cash items of $1,487,963, an increase in prepaid expenses and other current assets of $251,611, a decrease in due to related parties of $99,875 and a decrease in accounts payable, accrued expenses and other liabilities of $417,390.

Reworded

Net cash used in operating activities was $2,391,582$4,701,378 during the threesix months ended MarchJune 31,30, 2025,2026, which consisted primarily of a net loss adjusted adjusted for non-cash items of $1,912,659,$4,353,756, an increase in prepaid expenses and other current assets of $46,126,$276,132, a decrease in due to related partiesparty payable of $131,516,$73,125 and aan decreaseincrease in accounts payable and accrued liabilities of $301,281.$1,635.

Added

Net cash used in operating activities was $4,281,724 during the six months ended June 30, 2025, which consisted primarily of a net loss adjusted for non-cash items of $4,185,600, a decrease in prepaid expenses and other current assets of $48,192, a decrease in due to related parties of $133,016, and a decrease in accounts payable and accrued liabilities of $11,300.

Reworded

Net cash provided by financing activities was $2,503,208$8,348,207 during the threesix months ended MarchJune 31,30, 2026, which consisted of $1,204,793$5,552,765 in net proceeds from the sale of commonCommon stockStock and warrantswarrants, $1,523,242 of proceeds from warrant exercises, and $1,298,415$1,291,038 in net proceeds from the sale of commonCommon stockStock pursuant to the ATM Agreement. Agreement, offset slightly by $18,838 in payments of deferred offering costs.

Reworded

Net cash provided by financing activities was $4,448,914$4,898,010 during the threesix months ended MarchJune 31,30, 2025, which consisted of $4,373,870$4,244,467 in net proceeds from the sale of commonCommon stockStock, andnet warrants,of andoffering costs, $75,044 in proceeds from the exercise of warrants.warrants, and $578,499 in proceeds from Common Stock sold under the ATM Agreement, net of offering costs.

ENVB insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-06-01Coveney Kevin Michael
Chief Financial Officer
Grant/award 133,333— —180,746 SEC
2026-06-01Tucker Joseph Edward
Director, Chief Executive Officer
Grant/award 201,124— —271,479 SEC
2026-06-01Pasqualone Frank
Director
Grant/award 18,518— —26,423 SEC
2026-06-01Webb Michael D
Director
Grant/award 18,518— —26,416 SEC
2026-06-01Schabacker Marcus
Director
Grant/award 18,518— —26,418 SEC
2026-06-01Kegler George A.
Director
Grant/award 18,518— —26,418 SEC
2026-06-01Dewitt Sheila
Director
Grant/award 18,518— —26,306 SEC
2026-06-01Facchini Peter J.
Chief Innovation Officer
Grant/award 25,000— —27,755 SEC

Well-known investors holding ENVB (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Renaissance Technologies COM SHS2026-06-3032,058$44.2K0.0%New position
Citadel Advisors (Ken Griffin) COM SHS2026-06-3013,965$19.3K0.0%New position

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when ENVB files, watchlists and downloadable comparisons.