ENVB 10-K & 10-Q changes, risk factors and insider trading
Enveric Biosciences, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 890821 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
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
“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.”see in full comparison
“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.”see in full comparison
In connection with our development and future commercialization (if applicable) of our prospective products, we, and each contemplatedsee in full comparisonproductdrug candidate, are subject to theFederal Food DrugFDCA andCosmeticitsActimplementing(FDCA).regulations. The FDCAisdefinesintended 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 generallyeitherreceive premarket approval by FDA through the NDAprocess 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 notawardgrant premarket approval for ourproductdrug candidates through the NDA process, this will have a material adverse effect on our business, financial condition and results of operations.
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 thesee in full comparisonFederal Food Drug and Cosmetic Act (FDCA).FDCA. The FDCAis intended to assure the consumer, in part, that drugs and devices are safedefinesand effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and FDA regulations definethe 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 NDAprocess 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 notawardgrant premarket approval for ourproductdrug candidates through the NDA process, this could have a material adverse effect on our business, financial condition and results of operations.
“Our financial condition would be adversely impacted if our intangible assets become impaired”see in full comparison
“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. …”see in full comparison
Full comparison: every changed paragraph (67)
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:
Business and Financial Condition
Regulatory Matters
Intellectual Property
Common Stock
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
We may rely on third parties to plan and conduct preclinical studies and clinical trials.
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.
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.
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.
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.
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.
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.
Raw
Use of raw materials requiringrequires regulatory
approval
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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):
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Management's Discussion & Analysis (MD&A)
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”
Removed heading “Registered Direct Offerings”
Removed heading “Change in Fair Value of Warrant Liabilities”
Removed heading “Change in Fair Value of Investment Option Liability”
Removed heading “Inducement Expense”
Removed heading “Change in Fair Value of Derivative Liability”
Largest changes
“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. …”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (80)
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.
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.
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.
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.
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.
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.
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).
Neuroplastogens
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.
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.
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.
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:
Reverse
Stock Split
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.
Nasdaq
Bid Price Deficiency
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.
License
Agreement with MycoMedica Life Sciences
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.
License
Agreement with Aries Science and Technology
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.
Equity
Distribution Agreement
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.
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.
Lincoln
Park Equity Line
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.
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.
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.
Registered
Direct Offerings
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.
January
2025At the Market Offering
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.
Registered Direct Offering and Concurrent Private Placement
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.
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.
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.
December 2025 Inducement Warrant Transaction
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”).
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.
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.
Nasdaq Compliance on Minimum Bid Price Deficiency
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.
October 2025 Reverse Stock Split
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.
Nasdaq Compliance on Stockholders’ Equity Deficiency
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).
September 2025 Inducement Warrant Transaction
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.
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.
January 2025 Public Offering
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change
in Fair Value of Warrant Liabilities
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.
What changed in the latest 10-Q
Risk Factors
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
“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.”see in full comparison
“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. …”see in full comparison
“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.”see in full comparison
“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.”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
Full comparison: every changed paragraph (8)
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.
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.
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.
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.
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.
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.
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.
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)
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
“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. …”see in full comparison
“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.”see in full comparison
“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”). …”see in full comparison
Full comparison: every changed paragraph (39)
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
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:
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.
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.
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.
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.
The development status of the product is shown in the table below:
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:
Registered
Direct and Concurrent Private Placement
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.
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.
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).
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.
During the six months ended June 30, 2026, the Company issued 497,200 shares for net cash proceeds of $1,291,038.
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.
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.
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.
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).
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.
The
following table sets forth information comparing the components of net loss for the three months ended MarchJune 31,30, 2026 and 2025:
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.
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.
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.
The following table sets forth information comparing the components of net loss for the six months ended June 30, 2026 and 2025:
General and Administrative Expenses
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.
Research and Development Expenses
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.
Depreciation and Amortization Expense
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.
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.
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.
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.
Cash
Flows for the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025
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.
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.
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.
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.
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 date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-01 | Coveney Kevin Michael |
Grant/award | 133,333 | — | — |
| 2026-06-01 | Tucker Joseph Edward |
Grant/award | 201,124 | — | — |
| 2026-06-01 | Pasqualone Frank |
Grant/award | 18,518 | — | — |
| 2026-06-01 | Webb Michael D |
Grant/award | 18,518 | — | — |
| 2026-06-01 | Schabacker Marcus |
Grant/award | 18,518 | — | — |
| 2026-06-01 | Kegler George A. |
Grant/award | 18,518 | — | — |
| 2026-06-01 | Dewitt Sheila |
Grant/award | 18,518 | — | — |
| 2026-06-01 | Facchini Peter J. |
Grant/award | 25,000 | — | — |
Well-known investors holding ENVB (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 32,058 | $44.2K | 0.0% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 13,965 | $19.3K | 0.0% | New position |