A. [Reserved]
B. Capitalization
and Indebtedness
Not applicable.
C. Reasons
for the Offer and Use of Proceeds
Not applicable.
D. Risk
Factors
Our
business faces significant risks. You should carefully consider all of the information set forth in this Annual Report and in our other
filings with the SEC, including the following risk factors which we face and which are faced by the industries in which we operate. Our
business, financial condition or results of operations could be materially adversely affected by any of these risks. These disclosures
reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities
in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation
as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. This report also contains
forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in those forward-looking
statements, as a result of certain factors, including the risks described below and elsewhere in this report and our other SEC filings.
See “Special Note Regarding Forward-Looking Statements” on page 5.
Risks Related to Our Business and Industry
We have a history of operating losses and negative
cash flow, and we may never achieve or maintain profitability.
We have a history of losses, and incurred operating losses from
continuing operations of approximately $14.0 million, $18.8 million and $22.2 million for the years ended December 31, 2025, 2024
and 2023, respectively. There is no assurance that our efforts in developing our product candidates will result in commercially successful
products. We expect to continue to incur losses in future periods, until we begin earning significant revenues or royalties on our products,
the product candidates we are currently developing or any new product candidates we develop in the future, if at all. Because we will
incur significant costs and expenses for these efforts before we obtain any incremental revenues from them, our losses in future periods
could be significant. In addition, we may find that these efforts are more expensive than we anticipate or that they do not result in
profitability in the time period we anticipate, which would further increase our losses. For example, if we are unable to adequately control
the costs associated with operating our business, including our costs of development and sales, we may deplete our cash resources and
may be unable to continue to finance our business from our existing cash resources, and, our business, financial condition, operating
results and prospects will suffer. For more information concerning our cash resources, please see “Liquidity and Capital Resources”
in Item 5.B below.
Our management identified there were conditions that raised substantial
doubt about our ability to continue as a going concern for a period of one-year from the date this Annual Report. We have prepared a plan
to improve our available cash balances, liquidity and cash flows generated from operations. We have identified several potential actions,
including cost preservation measures that would be initiated in a timely manner to address our liquidity needs over the twelve-month period
from the date of this Annual Report. For more information concerning management’s plan, please see “Liquidity and Capital
Resources” and “Critical Accounting Estimates” in Items 5.B and 5.E, respectively, below.
8
Additionally, due to market conditions over the course of 2025,
and as part of an overall review of our organizational structure and its associated costs and expenses, we have implemented certain cost-cutting
measures, including a structural change and a significant reduction in work force during the year ended December 31, 2025, and may implement
additional cost-cutting measures in the future. During 2025, we streamlined activities outside our focus areas. We completed the
disposition of Lavie Bio’s assets to ICL (as defined below), where we sold the majority of Lavie Bio’s activity. Accordingly,
no further activity is expected at Lavie Bio. In addition, we scaled down Biomica’s operations by reducing staff and management
overhead. Biomica has licensed the BMC128 to Lishan (as defined below) and is now focused on completing its clinical trial for BMC128,
its immuno-oncology program by mid 2026. Accordingly, no further activity is expected at Biomica following the completion of the clinical
trial. Similar strategic dispositions and reductions in workforce were applied to the activities conducted by Casterra and AgPlenus.
Reductions in force may yield unintended consequences and costs, including additional attrition beyond the amount of force reduction,
distraction to our employees, reduced employee morale and adverse effects on our reputation as an employer. Such reductions in force may
also make it more difficult for us to hire new employees in the future and may limit the anticipated benefits from the reduction in force.
We, and our subsidiaries, may need substantial
additional capital in the future, which may cause dilution to our existing shareholders, restrict our operations or require us to relinquish
rights to our product candidates or intellectual property. If additional capital is not available, we may have to delay, reduce or cease
operations.
We and our subsidiaries may seek additional funding in the future,
which may consist of equity offerings, collaborations, licensing arrangements or any other means to develop our product candidates (including
through our subsidiaries and collaborators), fund research and data surveys, or other general corporate purposes. To the extent that we
raise additional capital through, for example, the sale of equity or convertible debt securities, our existing shareholders’ ownership
interest will be further diluted, and the terms may include liquidation or other preferences that adversely affect our shareholders’
rights. The incurrence of indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations
and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt or to issue additional
equity, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely
impact our ability to conduct our business. In addition, the issuance of additional equity securities by us, or the possibility of such
issuance, may cause the market price of our ordinary shares to decline. Securing additional financing may also divert our management’s
attention from our day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.
Additional funding may not be available to us on acceptable terms,
or at all. In the event that we enter into collaborations or licensing arrangements in order to raise capital, we may be required to accept
unfavorable terms, including relinquishing or licensing to a third party on unfavorable terms our rights to product candidates or intellectual
property that we otherwise would seek to develop or commercialize ourselves or reserve for future potential arrangements when we might
be able to achieve more favorable terms.
If we, or our subsidiaries, are unable to raise additional capital
when required or on acceptable terms, we may be required to:
• further delay, scale back or discontinue the development, manufacturing scale-up or commercialization of our or our subsidiaries’ product candidates;
• accept for one or more of our or our subsidiaries’ product candidates terms that are less favorable than might otherwise be available; or
• relinquish or license to additional parties, on unfavorable terms, our rights to our or our subsidiaries’ product candidates that we or our subsidiaries otherwise would seek to develop or commercialize ourselves.
Any such consequence will have a material adverse effect on our business, operating
results and prospects and on our ability to develop our or our subsidiaries’ product candidates ourselves or through collaborators.
9
Our shareholders may experience dilution in the future.
From time to time in the future, we may issue additional ordinary
shares or offer debt or other equity securities, including additional ordinary shares, warrants to purchase ordinary shares, or senior
or subordinated notes or other debt securities convertible into equity. Issuing additional ordinary shares, other equity securities or
securities convertible into equity may dilute the economic and voting rights of our existing shareholders, reduce the market price of
our ordinary shares or both. Debt securities convertible into equity could be subject to adjustments in the conversion rate pursuant to
which certain events may increase the number of equity securities issuable upon conversion. Our decision to issue securities in any future
offering will depend on market conditions and other factors, which may adversely affect the amount, timing or nature of our future offerings.
As a result, holders of our ordinary shares bear the risk that our future offerings may reduce the market price of our ordinary shares
and dilute their percentage ownership.
We currently have outstanding ordinary warrants to purchase up
to 5,076,924 ordinary shares. Any exercise, in whole or in part, of these warrants would dilute the holders of our ordinary shares. The
current exercise price of ordinary warrants is $1.25 per share. Whether or not the warrants are exercised will depend on the price of
our ordinary shares, and any exercise is at the discretion of the holders of the warrants. We may issue other warrants, options and derivative
securities in the future, which would also dilute the holders of our ordinary shares. See “Item 5. Operating and Financial Review
and Prospects— B. Liquidity and Capital Resources— Recent Public Offerings of Ordinary Shares.”
Our recent strategic streamlining and the reduction
of active subsidiaries and business lines increases our operational concentration risk and may reduce diversification benefits.
During 2025, we streamlined our operations, including the disposition
of certain assets and a reduction of activities in our subsidiaries. As a result, we are currently operating with a more limited number
of active subsidiaries and our business is now focused on fewer technological platforms, product candidates and revenue sources.
This increased concentration heightens our exposure to risks associated
with the remaining business activities. If our ChemPass tech engine, any of our subsidiaries, product candidates, collaborations or commercialization
efforts experience delays, technical setbacks, regulatory challenges, funding constraints, market resistance or other adverse developments,
the impact on our business, financial condition and results of operations may be more significant than in prior periods when our activities
were more diversified.
Our strategic focus may also reduce optionality for future growth
opportunities and may increase volatility in our operating results. If our remaining core activities do not achieve anticipated milestones
or commercialization objectives, we may have fewer alternative business lines to mitigate such setbacks, which could materially adversely
affect our long-term growth strategy and shareholder value.
The dilution of our equity holdings in our
subsidiary companies will likely negatively impact and/or decrease our results of operations, including revenues, and the benefits recognized
by our shareholders from value that may be created in such subsidiary companies.
Our corporate strategy and structure is intended to make product
development and go-to-market efficient and to reflect the individual value of each of our market focused business units. Under our corporate
structure, we operate as a developer of novel small molecule based therapeutics with Evogene acting as a technology hub and, below it,
divisions and subsidiaries that benefit from the unique capabilities of Evogene’s Computational Predictive Biology, or CPB, platform
and its technological engines, ChemPass AI and GeneRator AI. Each such subsidiary is responsible for advancing its product development
and pipeline, establishing its “go-to-market” strategy via direct sales or through existing and new collaborations, and securing
additional financial resources, if and when required. Due to our limited financial resources and other investment considerations, our
subsidiaries are permitted to obtain financing from external sources and have therefore raised additional capital and may continue to
raise capital in the future. Such financings can have a dilutive impact on our ownership interest in the particular subsidiary. For more
information see “Item 4.B. Information on the Company—Business Overview—Market Segments—Agriculture—Lavie
Bio Ltd.—Overview” and “Item 4.B. Information on the Company—Business Overview—Market Segments—Human
Health—Biomica Ltd.—Overview”. Such external financings have therefore resulted, and may continue to result, in the
decrease of our ownership percentage in one or more of our subsidiaries, which, in turn, will likely negatively impact and/or reduce our
operational results (including revenues), financial condition, long-term growth strategy, the value of our shares, and the benefits we
(and, indirectly, our shareholders) recognize from value established in any such subsidiary.
10
Our discoveries and product candidates may
not achieve the desired effect required in order to create commercially-viable products.
Our success depends on our ability to develop products that have
the desired effects: in our agriculture activity, on plants, in our human health activity, on humans, and in our industrial applications
activity, on the relevant industrial inputs. Research and development in these industries entails considerable uncertainty. We may spend
many years developing product candidates that will never be commercialized. The science underlying the development of our product candidates
is highly complex and, although we use innovative approaches, there is no certainty that our discoveries will result in product candidates
that satisfy market requirements. Except for our products in our castor oil activity, none of our discoveries and product candidates have
completed the development process and become commercially available so far and such anticipated products may never reach commercialization.
If our discoveries and product candidates will not have the desired effects, we and our collaborators may not develop commercial products
that are based on them, which could materially and adversely affect our results of operations and our long-term growth strategy.
If we are unable to maintain our CPB platform
and its technological engines, ChemPass AI and GeneRator AI, our research and development activities and those of our subsidiary companies
may be substantially reduced.
We and our subsidiary companies depend significantly on our CPB
platform and its technological engines in research and development activities. In particular, Evogene relies on CPB and its technological
engines to provide computational biology and computational chemistry services to our subsidiaries and to support our internal research
and development activities. If we are unable to maintain our CPB and technological engines, due to cost, technical failure or otherwise,
we could experience adverse consequences, including but not limited to loss of data, interruptions in research and development activities,
loss of business and revenues.
Our subsidiary companies rely on our CPB and its technological
engines to, among others, capture laboratory data, maintain clinical, greenhouse and field trial data and perform data analysis.
Therefore, if we are unable to maintain our CPB and technological engines, due to cost, technical failure or otherwise, our subsidiaries
could experience adverse consequences, including but not limited to loss of data (including clinical trial data) or damage to the integrity
of that data, interruptions in their research and development activities and other similar harms. Such surrounding circumstances may interrupt
our subsidiaries’ clinical trials, reduce demand for our subsidiaries’ product candidates, and delay or negatively impact
the development and commercialization of our subsidiaries’ product candidates and ability to grow and operate their business.
We completed the transition of technological engine, ChemPass AI,
from on-premises platform to Google Cloud Platform (GCP) services in June 2025. As a result, this exposes us to ongoing operational and
security risks that could materially affect our business operations and financial performance. While the initial migration has been completed,
we face continuing risks related to our increased dependency on third-party cloud service providers for critical business operations,
potential service interruptions outside our direct control, and cybersecurity threats inherent in cloud computing environments. The complexity
of our cloud infrastructure may result in technical issues that could cause system disruptions, data security incidents or unexpected
performance problems. We may experience challenges in maintaining compliance with evolving data privacy regulations across different jurisdictions
where our data is now stored and processed. Our operating costs may fluctuate based on cloud service consumption patterns and pricing
changes by our service providers. Additionally, while our workforce has been trained on cloud operations, any significant updates or changes
to the cloud platforms may require additional training and could temporarily impact operational efficiency. The concentration of our operations
in cloud environments may also limit our ability to quickly modify our infrastructure choices or service providers in response to future
business needs or cost considerations.
Various factors may delay, hinder, or prevent achievement of research
and development milestones and the commercialization of our product candidates.
Our success depends in part on our ability to identify discoveries
that will improve crop performance, in our agriculture activity, obtain clinical benefits, in our human health activity, or improve industrial
inputs, in our industrial applications activity. To develop these discoveries and product candidates into commercial products, we either
license them to collaborators or develop them independently through our subsidiaries or our Ag-Seeds division. Certain of our agreements
with our collaborators in our agriculture activity entitle us to upfront fees, research and development payments and milestone payments
once certain specified milestones are met. If we or our collaborators are not successful in reaching the established milestones in our
agreements, we may not receive the referenced research and development payments and milestone payments.
11
In addition, pursuant to our collaboration agreements in our agriculture
activity, we are usually entitled, subject to certain conditions, to receive royalties on products that are based on, or integrate, these
discoveries. Except for Casterra’s castor seed varieties, none of our current product candidates has completed the development process
and become commercially available. Therefore, we currently do not earn royalties and we do not derive significant sales revenues from
the sale of products based on our discoveries and product candidates. Thus, while our long-term growth strategy is based in large part
on the expectation that such royalties and revenues from product sales will comprise a significant portion of our revenues in the future,
we can provide no guarantee that any of our current or future product candidates will ever reach commercialization that would result in
royalty payments to us.
The manner in which we and our collaborators develop our product
candidates in our various fields of activity affects the period that will pass until such products are commercialized, if ever. Product
candidates based on our discoveries may never become commercialized for any of the following reasons:
▪ our discoveries and product candidates may not be successfully validated or may not have the desired effect required in order to become, or to be incorporated into, commercial products;
▪ the process of developing product candidates based on our discoveries is lengthy and expensive, and we or our collaborators may not be able to allocate the resources needed to complete such development within the desired timeline;
▪ we or our collaborators may decide to discontinue, pause, reduce, or alter the scope of the development efforts for our product candidates;
▪ we may fail to satisfy, in a timely manner or at all, relevant milestones under our agreements with our collaborators;
▪ regulatory conditions related to our product candidates may change in different territories, thus negatively affecting the relevant development processes and extending their length or limiting the commercialization of such product candidates;
▪ we or our collaborators may be unable to obtain the requisite regulatory approvals for product candidates based on our discoveries;
▪ our competitors may launch competing or more effective products;
▪ we or our collaborators may be unable to fully develop and commercialize product candidates containing our discoveries or may decide, for whatever reason, not to commercialize, or to delay the commercialization of, such product candidates;
▪ a market may not exist for products containing our discoveries or such products may not be commercially successful or relevant;
▪ we may be unable to protect the intellectual property underlying our discoveries in the necessary jurisdictions; and
▪ we may encounter production and scale-up challenges with respect to our product candidates that hinder their commercialization.
Thus, if our collaborators are not successful in reaching the established milestones
in our agreements or if we or our collaborators are not successful in commercializing products based on our discoveries, we will not realize
revenues from such products and we may not earn a profit on our discoveries, which could materially and adversely affect the results of
operations, financial condition and our long-term growth strategy, which may ultimately cause us to cease operations.
12
Our product development cycle is lengthy and
uncertain, and we may never sell or earn royalties on the sale of commercial products based on our discoveries.
Research and development in our fields of activity is expensive
and prolonged and entails considerable uncertainty. We may spend many years and dedicate significant financial and other resources developing
product candidates that will never be commercialized. The process of discovering, developing and commercializing ag-chemicals, small molecule
drugs, human microbiome-based therapeutics or castor varieties involves several phases and a long development period. The timelines
for development of product candidates by us or by our collaborators may extend beyond our expectations for many reasons, such as:
▪ we or our collaborators may not be able to allocate the resources needed to develop product candidates based on our discoveries;
▪ we or our collaborators may revise the process of product development or make other decisions regarding the product development pipelines that may extend the development period;
▪ we or our collaborators may prioritize other development activities ahead of development activities with respect to the product candidates on which we collaborate;
▪ our discoveries may not be successfully validated or may not have the desired effect sought by us or by our collaborators; and
▪ we or our collaborators may be unable to obtain the requisite regulatory approvals for the product candidates based on our discoveries within expected timelines or at all.
Most of the product candidates we or our collaborators are developing
are in early development stages. We have little to no certainty as to which and when, if any, any of these product candidates will eventually
reach commercialization. Because of the long product development cycle and the complexities and uncertainties associated with research
in our fields of activity, there is significant uncertainty as to whether we will ever generate significant revenues or royalties, if
any, from the product candidates that we or our collaborators are developing. Due to our limited financial and personnel resources, we
must focus on a limited number of research programs, drug candidates and specific indications. Our resource allocation decisions may cause
us to fail to capitalize on viable commercial products or profitable market opportunities. For more information on the product development
cycle of the product candidates we develop and a description of the phases of development, see the ‘Product Development Cycle’
paragraph under the description of each of our activity divisions and subsidiaries in “Item 4. Information on the Company—B.
Business Overview”.
If we are unable to efficiently produce and
scale up the production of our products, whether ourselves or through third party contractors, we may be unable to achieve our commercialization
targets.
When we introduce a product to the market, and in certain cases
even in later stages of product development, we need to establish efficient production capabilities for our products. In most cases, our
products are, or are expected to be, produced by third party producers with whom we contract for such purpose. The production of our products,
and the scale up of such production, are complicated processes that require expertise. The production of all of our subsidiaries’
current commercial products (mainly being castor beans of Casterra) relies, in all or in part, on third-party contractors. Failure to
establish a long-term relationship with a manufacturer with sufficient capacity, relevant cost of goods sold and sufficient quality, will
affect our subsidiaries’ ability to meet demand for their products. If we or our third-party contractors are unable to efficiently
produce and scale up production as needed to meet the demand for our products, we may be unable to achieve our commercialization targets,
which may, in turn, materially and adversely affect our future results of operations.
Due to mergers and consolidations, there is
a reduced number of companies in the agriculture industry with which we might establish strategic partnerships, and we rely on a limited
number of collaborators to develop and commercialize product candidates containing our seed trait and ag-chemical product candidates.
The agriculture markets are highly consolidated and dominated by
a relatively small number of large companies. In our agriculture operations, we are currently undertaking collaborations with several
of these companies to develop improved seed traits and ag-chemical product candidates. Due to the small number of major companies in this
industry, there are limited opportunities for us to grow our business with new collaborators. In addition, if we fail to develop or maintain
our relationships with any of our current collaborators, we could not only lose our opportunity to work with that collaborator, but we
could also suffer a reputational risk that could impact our relationships with other collaborators in what is a relatively small industry
community.
In our agriculture operations, we are currently working either
with collaborators or on independent projects to research and develop our different seed trait and ag-chemical product candidates. While
we seek to expand our portfolio of product candidates in the future, the research and development required to discover and develop new
product candidates is costly, time-intensive and requires significant infrastructure resources. If we are unable to enter into new collaborations,
or if we do not have the resources to develop the capabilities or resources necessary to discover and develop such product candidates
independently, we may not be able to expand our portfolio of these product candidates, which could have a material adverse effect on our
business prospects.
13
A decrease in research expenditures
by the major companies in our target markets may jeopardize the continuation, or scope, of our collaborations with such companies and
adversely impact our ability to continue or extend existing collaborations or enter into new collaborations on favorable financial terms.
The research and development expenditures of our existing and potential
collaborators in the agriculture, human health, and industrial applications markets we operate in may be reduced for reasons beyond our
control. For example, a global crisis or economic recession, a decrease in the prices of agricultural commodities, or the consolidation
trend in the seeds and ag-chemicals industries may result in decreased research and development expenditures in the markets relevant for
our pharmaceutical and ag-chemical product candidates. Such developments may, in turn, adversely impact our ability to maintain or extend
our existing collaborations or enter into new collaborations on favorable financial terms. For example, we may not be able to enter into
new collaborations under which our collaborators cover our expenses through research and development payments.
We or our collaborators may fail to perform
obligations under the collaboration agreements.
We are obligated under our collaboration agreements (including
grant agreements) to perform research activities over a particular period of time. If we fail to perform our obligations under these agreements,
in some cases our collaborators may terminate our agreements with them and in other cases our collaborators’ obligations may be
reduced, which may decrease our overall revenues. More specifically, in the event that a collaborator terminates our agreement (or reduces
its obligations thereunder), the research and development costs from the particular project, which were previously covered by such collaborator,
may be borne by us. Our overall revenues will therefore be reduced by the addition of such R&D costs. In addition, any of our collaborators
may fail to perform their obligations, which may hinder development and commercialization of products containing the product candidates
we develop and materially and adversely affect our future results of operations. Furthermore, the various payments we receive from our
collaborators are currently our primary source of revenues. If our collaborators do not make these payments, either due to financial hardship,
disagreement under the relevant collaboration agreement or for any other reason, our results of operations and business would be materially
and adversely affected. If disagreements with a collaborator arise, any dispute with such collaborator may negatively affect our relationship
with one or more of our other collaborators and may hinder our ability to enter into future collaboration agreements, each of which could
negatively impact our business and results of operations.
We are operating in multiple industries, each
of which consists of multiple companies with much greater resources than us. Competition in our industries is intense and requires continuous
technological development. If we are unable to compete effectively, our financial resources will be diluted and our financial results
will suffer.
We currently face significant competition in the markets in which
we operate. The agriculture, human health and industrial applications markets in which we operate are intensely competitive and rapidly
changing. Many companies engage in research and development of products in such markets, and being efficient in getting a new product
candidate to market can be a significant competitive advantage. In most segments of our operations, the number of products available to
the consumer is steadily increasing as new products are introduced by our competitors. We may be unable to compete successfully against
our current and future competitors, which may result in lower prices and margins than previously anticipated and the inability to achieve
market acceptance for our products. In addition, many of our competitors have substantially greater financial, marketing, sales, distribution
and technical resources than us. While the current market is centralized and tight, we anticipate that there may be increased competition
in the future as new companies enter these markets and new technologies become available. Our technologies may be rendered obsolete or
uneconomical by technological advances or entirely different approaches developed by one or more of our competitors or collaborators,
which will prevent or limit our ability to receive any associated research and development payments or generate revenues from the commercialization
of our product candidates.
14
We are working to develop and commercialize
novel small molecule-based therapeutics, and our efforts may be unsuccessful.
Evogene is actively leveraging AI-driven approaches to develop
its ChemPass AI platform to enable partnerships that will co-develop novel small molecule-based therapeutics, and our efforts may face
challenges and risks. Despite the potential of these innovative methods, our AI-driven drug discovery efforts may fail for various reasons,
including:
▪ Limitations of Predictive Models: Failure of Evogene’s AI model to accurately predict effective molecules or inability to identify molecules with the desired therapeutic profiles.
▪ Preclinical Failure: Failure of drug candidates to demonstrate efficacy or safety in preclinical studies despite promising computational predictions.
▪ Intellectual Property Risks: Failure to secure or maintain intellectual property protections for discovered molecules.
▪ Competition: Risk of being outcompeted by other organizations with similar or superior technologies.
▪ Regulatory Hurdles: Difficulty in navigating complex regulatory pathways, including obtaining necessary approvals for drug candidates or AI-related methodologies.
▪ Funding Constraints: Inability to secure adequate funding for drug development programs.
▪ Evolution of AI Regulations: Unanticipated changes in the regulatory landscape regarding AI in healthcare, which could impose additional compliance burdens or limit the application of certain technologies.
▪ Data Quality and Availability: Dependence on high-quality, diverse chemical and biological datasets to train models. Insufficient or biased data may lead to suboptimal or incorrect predictions.
▪ Integration with Experimentation: Difficulties in aligning computational outputs with laboratory validation workflows, lack of seamless integration between virtual predictions and experimental feedback loops for iterative learning.
▪ Infrastructure and Compute Constraints:
o High computational costs and infrastructure requirements for training and deploying advanced models.
o Dependence on cloud computing platforms or proprietary hardware, which may pose logistical or financial challenges.
▪ Algorithmic Limitations:
o Failure to enhance model accuracy in predicting molecular interactions, particularly for highly complex or novel targets.
o Difficulty in balancing generative AI design with constraints required for drug-likeness and manufacturability.
▪ Securing Strategic Partnerships:
o Challenges in forming partnerships with pharmaceutical or biotechnology and research organizations.
o Risk of over-reliance on external partners for critical workflows, leading to delays or disruptions if partnerships fail.
o Since we do not currently possess the resources necessary to independently develop and commercialize the majority of our drug candidates, we may seek to enter into collaborative agreements to assist in the development and potential future commercialization of some or all of these assets as a component of our strategic plan. However, our discussions with potential collaborators may not lead to the establishment of collaborations on acceptable terms, if at all, or it may take longer than expected to establish new collaborations, leading to development and potential commercialization delays, which would adversely affect our business, financial condition and results of operations.
▪ External Funding Challenges:
o Difficulty in securing sufficient funding to scale and continue development of ChemPass AI tools.
o Risk of reduced investor confidence if technological milestones are not achieved or if computational predictions fail to translate into successful experimental outcomes.
▪ Dependence on Collaborative Models:
o Reluctance from potential partners to adopt novel AI-based approaches due to skepticism or lack of familiarity with predictive tools.
o Challenges in demonstrating the commercial value of ChemPass AI tools to potential stakeholders without extensive validation data.
Success in early development does not indicate or guarantee that
later development will be successful. For example, drug candidates in later-stage clinical trials may fail to demonstrate sufficient safety
and efficacy despite having progressed through initial clinical trials and such candidates may never progress through later-stage trials.
15
We are working to develop and commercialize
novel ag-chemical products, and our efforts may be unsuccessful.
Our subsidiary, AgPlenus, is currently developing solutions for
crop protection through chemistry, or ag-chemistry. AgPlenus is developing these product candidates through a novel approach, focused
on biologically significant proteins called “targets”. AgPlenus’ efforts to develop novel ag-chemical product candidates
may fail for a variety of reasons, including:
▪ failure of its relatively novel target-based approach to lead to an effective product candidate or failure to identify chemical compounds that will display required level of performance;
▪ failure to establish cost-effective production of AgPlenus’ product candidates;
▪ failure to obtain and maintain patent and trade secret protection for its product candidates;
▪ failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third parties;
▪ inability to obtain sufficient funding to fully execute its ag-chemical business plan;
▪ one of our main research molecules suppliers is located in Ukraine, and has had, and may have in the future, limitations in access to molecules since the war in Ukraine, although such supplier has an alternative production site, and it is not our only supplier for research molecules;
▪ failure to meet regulatory requirements; and
▪ increase in regulatory requirements and limitations of use in various geographies on the use of ag-chemicals might decrease the potential market size for AgPlenus’ ag-chemical product candidates.
If AgPlenus’ efforts to develop ag-chemical product candidates
are unsuccessful, our results of operations could be negatively impacted.
We are working to develop and commercialize
seed-trait products, and our efforts may be unsuccessful.
We are developing seed-trait product candidates in our internal
Ag-Seeds division. Our efforts to develop novel product candidates may fail for a variety of reasons, including:
▪ failure to identify and develop candidate genomic elements having the desired effect on the target trait in the plant of interest;
▪ failure to obtain and maintain patent and trade secret protection for our product candidates;
▪ failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third parties;
▪ inability to obtain sufficient funding to fully execute the business plan;
▪ failure to successfully complete development of our seed trait product candidates; and
▪ our failure to meet regulatory requirements for seed trait product candidates.
Furthermore, even if we are able to discover and begin to develop
effective product candidates, we may not be successful if we are unable to find collaborators for further development and commercialization
of the product candidates. If our efforts to develop seed trait product candidates are unsuccessful, our results of operations could be
negatively impacted.
Biomica’s future prospects are substantially
dependent on a third-party licensee for the successful development and commercialization of its microbiome-based product candidate, BMC
128.
Biomica has licensed its microbiome-based product candidate,
BMC 128, to a third-party licensee and is expected to cease active operations following the completion of its Phase 1 clinical trials.
Any future value that Biomica may realize from this license agreement is substantially dependent on the licensee's efforts, resources,
and ability to advance BMC 128 through further development and commercialization, which remains highly uncertain. There can be no assurance
that the licensee will successfully develop or commercialize BMC 128 or that Biomica will realize any meaningful value from this arrangement
in the foreseeable future, if at all.
16
We are working to develop and commercialize
castor seeds for industrial applications, and our efforts may be unsuccessful in achieving a commercial presence in this market.
Our subsidiary, Casterra, is developing improved, high-yield castor
bean seeds for use as a source of non-edible feedstock for industrial uses of castor oil. The supply chain in the market of castor oil
for industrial uses is not well established and is evolving. In order for Casterra’s castor bean seeds to be an attractive feedstock
for oil for industrial uses, it will need to demonstrate on a commercial scale that its castor beans can reliably be used as a cost-efficient
feedstock for castor oil production. Casterra’s efforts to develop and commercialize castor been seeds for industrial uses may fail
for a variety of reasons, including:
▪ failure to reach desired yields of its castor seed varieties on a commercial scale to secure economic viability as bio-based oil feedstock;
▪ failure to establish efficient mechanical harvest and grain processing solutions;
▪ failure to establish a cost-effective production of castor bean grains, allowing grower profitability;
▪ failure to reach large scale adoption of castor by growers, including the successful management of diseases and pests;
▪ failure to address the health and environmental risks posed by castor bean seeds, which contain ricin, a naturally occurring poison;
▪ failure to comply with any regulatory requirement related to sales of castor beans, and in particular those related to the import of such beans and the potential effects of ricin;
▪ Our cultivation and agro-technical support activities in South America may be materially and adversely affected by an economic slowdown, uncertainties with respect to the legal system and violent crime or terrorism in these regions;
▪ failure to establish efficient and reliable production and scale up capabilities of castor seeds, independently or through third party contractors; and
▪ failure to engage new buyers for our seeds, increase the amounts of seeds we sell, or maintain the price paid for our seeds.
Casterra is operating in a new industry, with limited understanding
of the dynamics involved in producing and selling castor seeds. Casterra has made initial commercial sales of castor seeds; however, we
are unable to project the scope of additional sales and whether we will be able to increase or maintain our customer base. If Casterra
is unable to adequately address any of these challenges, we may not find a market for our castor bean seeds and our results of operations
could be materially and adversely affected.
Even if we are entitled to royalties from our
collaborators, we may not actually receive these royalties, or we may experience difficulties in collecting the royalties that we believe
we are entitled to, potentially resulting in costly litigation and loss of reputation.
If and when our collaborators launch commercial products containing
our licensed discoveries, we will rely on our collaborators to report to us the sales they earn from these products and to accurately
calculate the royalties we are entitled to, a process that will involve complicated calculations. Although we seek to address these concerns
in our collaboration agreements, such provisions may not be effective. Additionally, we may not be able to achieve our long-term goal
of generating revenues from royalties, and in the coming years our revenues will be entirely dependent on fees we earn for our research
and development services and milestone payments from our collaborators.
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In addition, our ability to generate royalty payments from our
collaboration agreements depends on our ability to clearly delineate our intellectual property rights under those agreements. We often
license patented discoveries and product candidates to our collaborators, who use them to develop and commercialize products. However,
a collaborator may use our intellectual property without our permission, dispute our ownership of certain intellectual property rights
or argue that our intellectual property does not cover their marketed product. If a dispute arises, it may result in costly litigation,
and our collaborator may refuse to pay us royalty payments while the dispute is ongoing. Furthermore, regardless of any resort to legal
action, a dispute with a collaborator over intellectual property rights may damage our relationship with that collaborator, and may also
harm our reputation in the industry.
Competition for highly skilled scientific, technical and other personnel
is intense, and as a result we may fail to attract, recruit, retain and develop qualified employees, which could materially and adversely
impact our business, financial condition and results of operations.
We compete for personnel in a research and development market characterized
by rapidly changing technologies and an evolving competitive landscape. In order for us to successfully compete and grow, we must attract,
recruit, retain and develop personnel with requisite qualifications to provide expertise across a range of disciplines, including biology,
chemistry, computer science and other fields relevant to our operations.
The number of qualified and highly educated personnel in the fields
upon which our business focuses in Israel, is limited and competition for the services of such persons is intense. Although we have employment
agreements with all of our employees, most of these agreements may be terminated on short notice by such employees, which may create an
immediate strain on our activities.
Historically and as of the date hereof, there has been intense
competition for qualified human resources in the Israeli high-tech and bio-tech industries. Although during 2025 there was a slight shift
in the attrition level and we were able to attract more candidates to each open position (mainly due to the financial slowdown in Israel),
we are still facing significant and intense competition in recruiting for our research and development positions.
Many of the companies with which we compete for qualified personnel
have significant resources, and we may not succeed in recruiting additional experienced or professional personnel, retaining personnel
or effectively replacing current personnel who may depart with qualified or effective successors. In addition, our employees may be increasingly
targeted for recruitment by competitors and other companies in the bio-tech and the high tech industry, which may make it more difficult
for us to retain employees and may increase retention costs. Training new employees with limited or no prior relevant experience could
be time-consuming, expensive and require significant resources.
In addition, as a result of the competition for qualified human
resources, the high-tech and bio-tech markets have also experienced and may continue to experience significant wage inflation. Accordingly,
our efforts to attract, retain and develop personnel may also result in significant additional expenses, which could adversely affect
our profitability. Furthermore, in making employment decisions, particularly in the high-tech and bio-tech industries, job candidates
often consider the value of the equity they are to receive in connection with their employment, which may force us to increase the amount
of equity awards we grant in order to recruit and retain talent.
In light of the foregoing, there can be no assurance that qualified
employees will remain in our employment or that we will be able to attract and retain qualified personnel in the future. Failure to retain
or attract qualified personnel could have a material adverse effect on our business, financial condition and results of operations.
We develop certain discoveries independent
of our collaborators, and we may need to finance the cost of the development of such product candidates ourselves.
We develop certain discoveries and product candidates independent
of our collaborators, with a goal of making such discoveries available to collaborators in later phases or developing and commercializing
end products. While we believe this will allow us to obtain more favorable license or commercialization terms with respect to such discoveries,
product candidates and products, the up-front cost to us of developing programs without a collaborator (and therefore without external
funding for the research and development expenditures we incur) in these early phases involves higher risks, since we need to fund the
research and development of such programs ourselves. If we are unsuccessful in discovering promising product candidates after having invested
significant funds, or if we are unable to find collaborators who are interested in such results and willing to fund subsequent phases
of development and commercialization, such failures could have a material and adverse effect on our business, financial condition and
results of operations. Regardless of the outcome of our research and development efforts, traditional financing sources such as bank financing
or public debt or equity financing, if available to us, could carry with them certain drawbacks, such as imposition of covenants restricting
our ability to operate, or substantial dilution to our existing shareholders.
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Our business (including each of the businesses
of our respective subsidiaries) and those of our collaborators are subject to various government regulations and, if we or our collaborators
are unable to comply with the relevant respective law and regulations and/or obtain the necessary regulatory approvals, we may not be
able to continue our operations.
Our business is generally subject to two types of regulations:
regulations that apply to our operations and regulations that apply to our product candidates and products. We and/or our collaborators
may fail to comply with all currently applicable regulations, and we and/or our collaborators may become subject to new or revised regulations
or approvals in the future. Furthermore, any violation of these regulations by us and/or our collaborators may expose us to civil and
criminal penalties.
Specifically, our operations are carried out mainly in Israel and
accordingly we are regulated by the Israeli Ministry of Agriculture and Rural Development, or ISARD, and more specifically by the ISARD’s
Plants Protection and Inspection Services and the National Committee for Transgenic Plants. The regulation by ISARD addresses, among other
things, the import of agricultural materials into Israel, environmental protection requirements for our experiments and working with transgenic
plants.
Additionally, our research and development activities use chemicals
and produce waste materials, which require us to hold business licenses that may include conditions set by the Israeli Ministry of Environmental
Protection for the operations of such facilities.
Our operations in the human health sector, namely the clinical
trial by our subsidiary Biomica, are regulated by various laws, regulations, orders and procedures by the Israeli Ministry of Health.
In particular, our clinical trials require a permit for a research plan (protocol) by the Helsinki Committee, operating under the Public
Health Regulations (Clinical Trials in Humans), 1980 and are also regulated by the Israeli Public Health Ordinance, 1940.
If we fail to comply with any of the above-mentioned laws and/or
regulations, we may be subject to fines and other civil, administrative or criminal sanctions (i.e., imprisonment), including the revocation
of our toxin permits, business permits, or other permits and licenses necessary to continue our business activities.
If we develop a commercialized product(s), we further anticipate
that we, our subsidiaries, and/or our collaborators, will need to apply for regulatory approval of certain products and may also become
subject to additional regulatory regimes in the sale of such products. Such laws may include laws that govern which product(s) may be
sold in a particular jurisdiction along with the manner of sales and marketing permitted in that particular jurisdiction. Such laws may
be onerous to comply with and may vary from jurisdiction to jurisdiction. For example, in the United States, the regulation of biotechnology
is divided among the United States Environmental Protection Agency, or EPA, which regulates activity related to the invention of plant
pesticides and herbicides, the United States Department of Agriculture, which regulates the import, field testing and interstate movement
of specific technologies that may be used in the creation of transgenic plants, and the United States Food and Drug Administration, or
the FDA, which regulates foods derived from new plant varieties. As a result, certain of our products may have to be approved for sale
by separate agencies that may regulate a different aspect of one or more of our future products.
In addition, with respect to our product candidates in the human
health sector, the time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically
takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion
of the regulatory authorities. In addition, approval policies, laws or regulations, or the type and amount of clinical data necessary
to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It
is possible that none of our existing product candidates or any product candidates that we may seek to develop in the future will ever
obtain regulatory approval. This lengthy approval process as well as the unpredictability of future clinical trial results may result
in the failure to obtain regulatory approval to market any of our product candidates as part of our collaborator products, which would
significantly harm our underlying businesses, financial condition and results of operations. The FDA and comparable foreign regulatory
authorities have substantial discretion in the approval process, and determining when or whether regulatory approval will be obtained
for any of our product candidates. Prior to obtaining approval to commercialize a product candidate in the United States or elsewhere,
we or our collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the
FDA or comparable foreign regulatory agencies, that such product candidates are safe and effective for their intended uses. Results from
nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the data collected from clinical trials
of our product candidates is promising, such data may not be sufficient to support approval by the FDA or comparable foreign regulatory
authorities.
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If we, our subsidiaries, or our collaborators are unable to obtain
the requisite regulatory approvals or there is a delay in obtaining such approvals as a result of negative market perception or heightened
regulatory standards, such product candidates will not be commercialized, which would negatively impact our business and results of operations.
Disruption to our information technology and
systems, or those of our subsidiaries, including a security breach or unauthorized access to our data, our customer’s data, or our
platform, could adversely affect our reputation and future demand for our products or collaborative relationships, which may have a material
adverse effect on our business and results of operations.
Our computational technologies rely on our information technology,
or IT, system to collect and analyze the biological and chemical data, which includes several petabytes of data that we produce,
review, and store. Our IT is also involved with the collection, storage, processing, transmission and other use of data, including certain
confidential, sensitive, and personal information, including those relating to our research, studies, and participants. More generally,
in the ordinary course of our business, we collect, store, transmit and otherwise process large amounts of sensitive corporate, personal
and other information, including intellectual property, proprietary business information, and other confidential information. Any security
breach, data loss, or other compromise, including those resulting from a cybersecurity attack, phishing attack, or any unauthorized access,
unauthorized usage, virus or similar breach or disruption could result in the loss or destruction of or unauthorized access to, or use,
alteration, disclosure, or acquisition of, data, damage to our reputation, loss of intellectual property protection, claims and litigation,
regulatory investigations, or other liabilities. For example, we may become the target of cyber-attacks by third parties seeking unauthorized
access to our or our customers’ data or to disrupt our ability to provide our services. These attacks may come from individual hackers,
criminal groups, and state-sponsored organizations. Ransomware attacks, including those from organized criminal threat actors, nation-states,
and nation-state supported actors, are becoming increasingly prevalent and severe, and can lead to significant interruptions in our operations,
loss of data and income, reputational loss, diversion of funds, and may result in fines, litigation and unwanted media attention. Extortion
payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for
example, applicable laws or regulations prohibiting payments. Additionally, companies have, in general, experienced an increase in phishing,
social engineering and other attacks from third parties, and the increase in remote working further increases these and other security
threats. While we are constantly subject to common cyber-attacks including phishing, hacking, encryption, viruses, man/monkey in the middle,
etc. from time-to-time, as of the date of this Annual Report, we have not reasonably identified any confirmed breach of our systems and
therefore do not believe that any such attacks have individually or in the aggregate led to costs or consequences which have materially
impacted our operations or business.
If our security measures are breached as a result of third-party
action, employee error or negligence, a defect or bug in our offerings or those of our third-party service providers, malfeasance or otherwise
and, as a result, someone obtains unauthorized access to any data, including our confidential, sensitive, or personal information or the
confidential, sensitive, or personal information of our customers, or other persons, or any of these types of information is lost, destroyed,
or used, altered, disclosed, or acquired without authorization, or if any of the foregoing is perceived to have occurred, our reputation
may be damaged, our business may suffer, and we could incur significant liability, including under applicable data privacy and security
laws and regulations.
Even the perception of inadequate security may damage our reputation
and market position, negatively impacting our ability to win new customers and retain and receive timely payments from existing customers.
Further, we could be required to expend significant capital and other resources to protect against and address any data security incident
or breach, which may not be covered or fully covered by our insurance, and which may involve payments for investigations, forensic analyses,
regulatory compliance, breach notification, legal advice, public relations advice, system repair or replacement, or other services. We
and our collaborators, subsidiaries, and service providers also may face difficulties or delays in identifying or responding to, and remediating
and otherwise responding to, cyberattacks and other security breaches and incidents. We have made significant efforts to protect against
and address potential impacts of security breaches and incidents (such as applying fire walls and segregation of networks), and anticipate
doing so in the future. Additionally, we may be required to notify such breaches to regulators and/or individuals and operate to mitigate
damages, which may result in us incurring additional costs.
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Our subsidiaries, collaborators, and other service providers store
and otherwise process our data, including personal, confidential, sensitive, and other information about individuals and ongoing research
projects. Such entities may also be the targets of cyberattacks, malicious software, phishing schemes, and fraud. Our ability to monitor
the data security of such entities is limited, and, in any event, bad actors may be able to circumvent such security measures, resulting
in the unauthorized access to, misuse, acquisition, disclosure, loss, alteration, or destruction of our data, including confidential,
sensitive, and other information about individuals and our ongoing research.
Techniques used to sabotage or obtain unauthorized access to systems
or networks are constantly evolving and, in some instances, are not identified until after they have been launched against a target. We,
our subsidiaries, collaborators, and our service providers may be unable to anticipate these techniques, react in a timely manner, or
implement adequate preventative and mitigating measures. If we are unable to efficiently and effectively maintain and upgrade our system
safeguards, we may incur unexpected costs and certain of our systems may become more vulnerable to unauthorized access or disruption.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, market position,
and reputation.
We have established an internal information security committee,
that meets from time to time to provide guidelines and address security issues, but we can provide no assurance that our current IT system
is fully protected against third-party intrusions, viruses, hacker attacks, information or data theft or other similar threats. Disruption
or failure of our IT system due to technical reasons, cyberattacks, natural disasters or other unanticipated catastrophic events, including
power interruptions, storms, fires, floods, earthquakes, terrorist attacks and wars could significantly impair our internal development
efforts. We maintain an off-site data recovery system that is used for the retention of critical data to enable a potential recovery
in case of any of the described disasters (however, this system is not designated to create seamless continuity operation).
As we continue to develop our computational technologies and expand
our datasets, we may need to update our IT system and storage capabilities. However, if our existing or future IT system does not function
properly, or if the IT system proves incompatible with our new technologies, we could experience interruptions in data transmissions and
slow response times, preventing us from completing routine research and business activities, which could adversely affect our business
and results of operations.
Development of our product candidates, particularly
during our validation and testing activities, may be adversely affected by circumstances caused by us or those beyond our control.
The industries we are engaged in are subject to various factors
that make our operations relatively unpredictable from period to period. For example, the testing of our product candidates may be adversely
affected by circumstances both caused by us and those that are beyond our control. Factors caused by us include any failure by us or our
collaborators to follow proper agronomic practice or suggested protocols for conducting our experiments, and failure to successfully complete
such experiments. Factors beyond our control include weather and climatic variations, such as droughts or heat stress, or other factors
we are unable to identify. For example, if there was prolonged or permanent disruption to the electricity, climate control or water supply
operating systems in our greenhouses or laboratories, the plants and pests on which we test our discoveries and product candidates and
the samples we store in freezers, both of which are essential to our research and development activities, would be severely damaged or
destroyed, adversely affecting our research and development activities and thereby our business and results of operations. We have experienced
these kinds of failures in the past for unknown reasons, causing delays in our achievement of milestones and delivery of results, and
necessitating that we re-start the trials. Any test failure we may experience is not covered by our insurance policy, and therefore could
result in increased cost of the trials and development of our product candidates, which may negatively impact our business and results
of operations.
Our business could be disrupted
by catastrophic events.
The occurrence of unforeseen or catastrophic events such as terrorist
attacks and war (as further detailed below in the section titled “Risks Relating to Our Incorporation and Location in Israel”),
extreme terrestrial or solar weather events or other natural disasters, emergence of a pandemic, or other widespread health emergencies
(or concerns over the possibility of such an emergency), could create economic and financial disruptions, and could lead to operational
difficulties that could impair our ability to manage our business.
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Consumer and government resistance to genetically
modified organisms, or GMOs, may negatively affect our public image and reduce potential sales of plants containing our traits.
A certain part of our seed traits activity includes research and
development of genetically modified, or GM, seeds. Foods made from such seeds are not accepted by many consumers and in certain countries
production of certain GM crops is effectively prohibited, including throughout the European Union, or EU, due to concerns over such products’
effects on food safety and the environment. Other jurisdictions and governmental authorities, including in South America and Asia, are
increasingly taking an interest in regulating agricultural products of biotechnology. Regulatory approaches vary by jurisdiction as a
result of the existing public health frameworks and phytosanitary laws, as well as other less tangible factors such as cultural and religious
norms that may have an impact on individual country risk assessments and decision-making. Each jurisdiction may have its own regulatory
framework, which may include restrictions and regulations on planting and growing genetically engineered plants, import of grain and other
plant products, and in the consumption and labeling of feed and foods derived from such novel plants, and which may apply to future products
containing our traits. The high public profile of biotechnology agriculture, especially in food production, and lack of consumer acceptance
of products to which we have devoted substantial resources could negatively affect our public image and results of operations. For example,
the prohibition on the production of certain GM crops in select countries and the current resistance from consumer groups, particularly
in Europe, to GM crops not only limits our access to such markets but also has the potential to spread to and influence the acceptance
of products developed through biotechnology in other regions of the world and may also influence regulators in other countries to limit
or ban production of GM crops, which could limit the commercial opportunities to exploit biotechnology. Moreover, regulation of all genetically
engineered plants in the EU is far more stringent than in the U.S. and Canada. U.S. and Canadian regulators have determined that genome
edited plants pose fewer risks than traditional biotechnology-derived plants subjected to modification through the insertion of recombinant
DNA. In contrast, a recent EU legal ruling indicated that the existing EU regulations for genetically engineered plants modified by the
insertion of recombinant DNA, which were already more stringent than corresponding U.S. and Canadian regulations, should be strictly applied
to genome edited plants as well. As a result, there is a sharp distinction between how EU and U.S. and Canadian regulatory agencies oversee
novel seed traits, and in particular those that are generated using the more modern techniques of genome editing.
Although we are not currently targeting EU markets for the development
or commercialization of future products containing our traits, emerging oversight regimes for genetically engineered products in other
jurisdictions may follow the EU approach and impose similarly strict requirements for the release of such products into the environment
and their incorporation into human food or other consumer products. Such jurisdictions may also elect to regulate genetically engineered
plants without distinguishing between traditional biotechnology-derived plants modified with recombinant DNA and genome edited plants.
There is no guarantee that countries for which we may have or may develop future marketing plans would not take a stricter legal and regulatory
approach to controlling genetically engineered plants similar to that of the EU, which could increase regulatory costs and delay, prevent
or limit our or our future collaborators’ ability to market our traits in such jurisdictions.
GM crops are grown principally in the United States, Brazil and
Argentina where there are fewer restrictions on the production of GM crops. If these or other countries where GM crops are grown enact
laws or regulations that ban the production of such crops or make regulations more stringent, we could experience a longer product development
cycle for our product candidates and may even have to abandon projects related to certain crops or geographies, both of which would negatively
affect our business and results of operations and could cause us to have to cease operations. Furthermore, any changes in such laws and
regulations or consumer acceptance of GM crops could negatively impact our collaborators, who in turn might terminate or reduce the scope
of their collaborations with us or seek to alter the financial terms of our agreements with them.
We currently need, and in the future we may
need to obtain licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms,
and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
We currently need, and in the future we may be required to license
technology from third parties to further develop or commercialize our investigational products. Should we be required to obtain licenses
for any third-party technology, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to
obtain any third-party license required to develop or commercialize any of our products could cause us to abandon any related efforts,
which could seriously harm our business and operations.
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The licenses we grant to our collaborators
to use our discoveries are in most cases exclusive with respect to a specified discovery, product type or market area. This may limit
our opportunities to enter into additional licensing or other arrangements with respect to such discoveries, product types or market areas.
Most of the licenses we grant our collaborators to our product
candidates or to use specific discoveries we have made are exclusive in the market area of the license. That means that once these discoveries
are licensed to a collaborator, we are generally prohibited from licensing those discoveries to any third party for use in such area.
The limitations imposed by these exclusive licenses could prevent us from expanding our business and increasing our exposure to new licensees,
both of which could adversely affect our business and results of operations.
We may be required to pay substantial damages
as a result of product liability, warranty liability, or personal injury claims and litigation.
Once products integrating our discoveries and product candidates
reach commercialization, if ever, product liability, warranty liability, personal injury, or other litigation claims may become a commercial
risk to our business, particularly as some of the products that we develop may be harmful to humans or to the environment. Moreover, as
our portfolio of available products expands, we may experience increases in product liability claims asserted against us. Courts have
awarded substantial damages in the United States and elsewhere against a number of companies in the agriculture and human health industries
in past years based upon claims for injuries allegedly caused by the use of their products. Product liability claims against us and/or
our collaborators selling products that contain our product(s) or allegations of product liability relating to products containing our
discoveries may damage our reputation, harm our relationships with our collaborators, and materially and adversely affect our business,
results of operations, financial condition and prospects. Currently, we and/or our subsidiaries maintain an insurance policy according
to the specific needs of each company, which may include commercial insurance, self-insurance (including direct risk retention), or a
combination of both approaches, in amounts and on terms that we believe are reasonable and prudent in light of our business and related
risks. We currently carry specific product liability insurance coverage for Casterra. Any such insurance we obtain on these operations
may be expensive and may not cover our potential liability in full. In addition, we may be subject to claims for which insurance coverage
that we do carry is denied, as well as claims that exceed our policy limits. As a result, we may not be able to obtain the type and
amount of insurance we desire, or any insurance on reasonable terms, in the markets in which we operate. Furthermore, while our collaboration
agreements typically require that our collaborators indemnify us for the cost of product liability claims brought against us, such indemnification
provisions may not be enforceable, and we may receive no indemnification if our own misconduct led to the claims.
Any litigation could force us to incur significant expenses,
divert management’s time and attention, subject us to adverse publicity, and damage our reputation and competitive position. A successful
assertion of a claim against us may result in potentially significant monetary damages, penalties, or fines and adversely affect sales
of our products. Costs or payments made in connection with warranty and product liability claims and recalls could adversely affect our
financial condition and results of operations in a material manner.
Our facilities in Israel are located on leased
properties. Termination of any of the leases, changes in lease terms, and long-term leases that may not be terminated at will, may jeopardize
our activity and materially affect our financial condition or results of operations.
Our office spaces, labs, facilities, and farm are all situated
on properties that we lease pursuant to lease agreements in Israel. Once a lease agreement ends, we may not be able to renew it on favorable
terms, or not at all, which may require us to increase our lease payments or take a new lease on another property, adversely affecting
our business and results of operations. In addition, a long-term lease may mean no or limited possibility to terminate the lease at will
before the completion of the lease period, which may lead to continued holding of an un-needed space or entry into a sub-lease, which
may adversely affect our results of operations. For more information regarding our facilities, please see “Item 4. Information on
the Company—D. Property, Plants and Equipment.”
Our operations are subject to various health
and environmental risks associated with our use, handling and disposal of potentially toxic materials.
Our operations involve various health and environmental risks.
For example, as part of our seed traits operations, we assist in the development of GM crops by inserting new genes into the genomes of
certain plants. Though we introduce these genes in order to improve plant traits, we cannot always predict the effect that these genes
may have on the plant. In some cases, the genes may render the plant poisonous or toxic, or they may cause the plant to develop other
dangerous characteristics that could harm the plant’s surrounding environment. Furthermore, while we comply with relevant environmental
laws and regulations, there is a risk that, when testing genetically modified plants, the seeds of these plants may escape the greenhouse
in which they are being tested and contaminate nearby fields. Poisonous or toxic plants may therefore be inadvertently introduced into
the wild, or possibly enter the food production system, harming the people and animals who come in contact with them. Furthermore, GM
crops may be a source for the transfer of antibiotic-resistant genes to the environment or the exposed organisms.
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In addition, as part of Casterra’s operations, we handle
castor seeds, which contain ricin, a naturally occurring poison, and hence are unsuitable for human or animal consumption. Ricin is a
naturally occurring carbohydrate-binding protein produced in the seeds of ricinus communis, the plant that produces castor oil. It is
toxic when inhaled, ingested, or injected. As few as five to ten micrograms per kilogram can be lethal. The risk may occur when practicing
a crop rotation scheme that involves growing an edible crop after castor. There is a risk that the harvesting machinery will not properly
harvest seeds; and if the harvesting machinery fails to remove the castor seeds properly, there is a risk the seeds could germinate and
develop into a plant, which may be collected during the second crop harvest and contaminate the edible yield with a toxic substance.
Similar risks are relevant to our Ag-Seeds division operations,
especially with respect to GM seeds and AgPlenus’ ag-chemicals operations.
Changes in laws and regulations to which we
are subject, or to which we may become subject in the future, may materially increase our costs of operation, decrease our operating revenues
and disrupt our business.
Laws and regulatory standards and procedures that impact our business
are continuously changing. Responding to these changes and meeting existing and new requirements may be costly and burdensome. Changes
in laws and regulations may occur that could:
▪ impair or eliminate our ability to research and develop our product candidates, including validating our product candidates through lab, greenhouse, field or clinical trials;
▪ increase our compliance and other costs of doing business through increases in the cost to patent or otherwise protect our intellectual property or increases in the cost to our collaborators to obtain the necessary regulatory approvals to commercialize and market the product candidates we develop with them;
▪ require significant product redesign or systems redevelopment;
▪ render our product candidates less profitable, obsolete or less attractive compared to competing products;
▪ affect our collaborators’ willingness to do business with us;
▪ jeopardize import or export of raw material or end products, such as with respect to seedlings and products;
▪ reduce the amount of revenues we receive from our collaborators through milestone payments or royalties; and
▪ discourage our collaborators from offering, and consumers from purchasing, products that incorporate our discoveries.
Any of these events could have a material adverse effect on our
business, results of operations and financial condition. For example, legislators and regulators have increased their focus on plant biotechnology
in recent years, with particular attention paid to GM crops as well as on ag-chemicals.
While none of our product candidates are currently available for
sale, other than Casterra’s castor seeds, our future growth relies on our ability and the ability of our collaborators to commercialize
and market our product candidates, and any restrictions on such activities could materially and adversely impact our business and results
of operations. Any changes in regulations in countries where our product candidates are used could result in our collaborators being unable
or unwilling to develop, commercialize or sell products that incorporate our discoveries. In addition, we rely on patents and other forms
of intellectual property protection. Legislation and jurisprudence on patent protection in the key target markets where we seek patent
protection, such as the United States and the EU, is evolving and changes in laws could affect our ability to obtain or maintain patent
protection for our product candidates. Any changes to these existing laws and regulations may materially increase our costs of operation,
decrease our operating revenues and disrupt our business. For more information, please see ‘Government Regulation of our Operations’
and ‘Government Regulation of Product Candidates’ paragraphs under the description of each of our activity divisions and subsidiaries
under “Item 4. Information on the Company—B. Business Overview.”
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We are subject to evolving corporate governance
and public disclosure regulations and expectations, including with respect to environmental, social and governance matters that could
expose us to numerous risks.
We are subject to changing rules and regulations promulgated by
a number of governmental and self-regulatory organizations, including the SEC and Nasdaq. These rules and regulations continue to evolve
in scope and complexity and many new requirements have been created in response to laws enacted by Congress, making compliance difficult
and uncertain, including the recent change to require directors and officers of foreign private issuers like us to the reporting obligations
of Section 16 of the Exchange Act. The SEC is also currently reviewing additional possible rule changes for foreign private issuers. In
addition, increasingly regulators, customers, investors, employees and other stakeholders are focusing on environmental, social and governance,
or ESG, matters and related disclosures. These changing rules, regulations and stakeholder expectations could result in increased general
and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.
For example, developing and acting on ESG initiatives, and collecting, measuring, and reporting ESG information and metrics, can be costly,
difficult and time consuming and is subject to evolving reporting standards. We may also communicate certain initiatives and goals regarding
environmental matters, diversity, responsible sourcing, social investments and other ESG matters in public disclosures. These initiatives
and goals could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not
advance at a sufficient pace, and ensuring the accuracy, adequacy, or completeness of the disclosure of our ESG initiatives can be costly,
difficult and time-consuming. We may be affected by market or regulatory responses to climate change.
Growing public concern about climate change has resulted in the
increased focus of local, state, regional, national and international regulatory bodies on greenhouse gas, or GHG, emissions and climate
change issues.
We may also incur additional expenses as a result of regulators
requiring additional disclosures regarding GHG emissions. Compliance with such regulations and the associated potential cost is complicated
by the fact that various countries and regions are following different approaches to the regulation of climate change.
Growing cycles and adverse weather conditions may decrease our
results from operations.
Our operations are affected by the growing cycles of the crops,
including castor beans, that we plant, test and manufacture for our and our subsidiaries’ products. We set our planting schedules
without knowing the effect of the weather on the crops or on the entire industry’s production. Weather conditions during the course
of each crop’s growing season will affect the volume and growing time of that crop.
Risks Related to Our Intellectual Property Rights
Our success depends on our ability to protect
our intellectual property and our proprietary technologies.
Our commercial success depends in part on our ability to obtain
and maintain patent protection and trade secret protection for our proprietary computational and experimental technologies, our discoveries
and their uses, as well as our ability to operate without infringing upon the proprietary rights of others. If we do not adequately protect
our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage we may have,
which could harm our business and ability to achieve profitability.
While we expect our patent applications to receive approval, we
cannot be certain that we will obtain such results. Despite our efforts to protect our proprietary rights, unauthorized third parties
may attempt to use, copy or otherwise obtain and market or distribute our intellectual property rights or technology or otherwise develop
products or solutions with the same functionality as our solutions. For example, the castor varieties of our subsidiary Casterra
can be easily reproduced by any third party with access to its castor seeds. In addition, the laws of some foreign countries provide less
protection for proprietary rights than U.S. law. We face the occasional risk, moreover, that third parties may assert copyright, trademark
and other intellectual property rights against us. Such claims may result in direct or indirect liability as we have contractually agreed
to indemnify certain parties for any damages suffered as a result of infringement by us of any third-party intellectual property rights.
Policing unauthorized use of technologies, trade secrets and intellectual property may be difficult, expensive and time-consuming. If
we fail to meaningfully establish, maintain, protect and enforce our intellectual property and proprietary rights, our business, operating
results and financial condition could be adversely affected.
25
If we are unable to protect the confidentiality
of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
We treat our proprietary computational and experimental technologies,
including unpatented know-how and other proprietary information, as trade secrets. We seek to protect these trade secrets, in part, by
entering into non-disclosure and confidentiality agreements with any third parties who have access to them, such as our consultants, independent
contractors, advisors, corporate collaborators and outside scientific collaborators. We also enter into confidentiality and invention
or patent assignment agreements with employees and certain consultants. Any party with whom we have executed such an agreement may breach
that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies
for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming,
and the outcome is unpredictable. In addition, if any of our trade secrets were to be lawfully obtained or independently developed by
a competitor, we would have no right to prevent such third party, or those to whom it communicates that technology or information, from
using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed
by a competitor, or if we otherwise lose protection for our trade secrets or proprietary know-how, the value of this information may be
greatly reduced and our business and competitive position could be harmed.
We may not be able to protect our intellectual
property rights throughout the world.
Filing, prosecuting, maintaining and defending patents on product
candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries
outside the United States are less extensive than those in the United States. In addition, the laws of some foreign countries do not protect
intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we are unable to prevent
third parties from using our inventions in all countries outside the United States, or from selling or importing products made using our
inventions in and into the jurisdictions in which we do not have patent protection. Competitors may use our technologies in jurisdictions
where we have not obtained patent protection to develop their own products, and we may be unable to prevent such competitors from importing
those infringing products into territories where we have patent protection but enforcement is not as strong as in the United States. These
products may compete with our product candidates and our patents and other intellectual property rights may not be effective or sufficient
to prevent them from competing in those jurisdictions. Moreover, farmers or others in the chain of commerce may raise legal challenges
against our intellectual property rights or may infringe upon our intellectual property rights, including through means that may be difficult
to prevent or detect. For example, the practice by some farmers of saving seeds from non-hybrid crops (such as soybeans, canola and cotton)
containing biotechnological traits may prevent us from realizing the full value of our intellectual property in countries outside of the
United States.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in foreign jurisdictions, including China. The legal systems of certain countries, including
China, have not historically favored the enforcement of patents or other intellectual property rights, which could hinder us from preventing
the infringement of our patents or other intellectual property rights and result in substantial risks to us. Proceedings to enforce our
patent rights in the United States or foreign jurisdictions could result in substantial costs and divert our efforts and attention from
other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications
at risk of not issuing and could provoke third parties to assert patent infringement or other claims against us. We may not prevail in
any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our
efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from
the intellectual property that we develop or license from third parties.
If we or one of our collaborators are sued for infringing the intellectual
property rights of a third party, such litigation could be costly and time consuming and could prevent us or our collaborators from developing
or commercializing our product candidates.
Our ability to generate significant revenues from our product candidates
depends on our and our collaborators’ ability to develop, market and sell our product candidates and utilize our proprietary technology
without infringing the intellectual property and other rights of any third parties. In the United States and abroad there are numerous
third-party patents and patent applications that may be applied toward our proprietary technology, business processes or product candidates,
some of which may be construed as containing claims that cover the subject matter of our product candidates or intellectual property.
Because of the rapid pace of technological change, the confidentiality of patent applications in some jurisdictions, and the fact that
patent applications can take many years to issue, there may be currently pending applications that are unknown to us that may later result
in issued patents upon which our product candidates or proprietary technologies infringe. Similarly, there may be issued patents relevant
to our product candidates of which we are not aware. These patents could reduce the value of the product candidates we develop or, to
the extent they cover key technologies on which we have unknowingly relied, require that we seek to obtain licenses or cease using the
technology, no matter how valuable to our business. We may not be able to obtain such a license on commercially reasonable terms. There
is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology industry generally.
If any third party patent or patent application covers our intellectual property or proprietary rights and we are not able to obtain a
license to it, we and our collaborators may be prevented from commercializing products containing our discoveries.
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As the biotechnology industry continues to develop, we may become
party to, or threatened with, litigation or other adverse proceedings regarding intellectual property or proprietary rights in our technology,
processes or product candidates. Third parties may assert claims based on existing or future intellectual property rights and the outcome
of any proceedings is subject to uncertainties that cannot be adequately quantified in advance. Any litigation proceedings could be costly
and time consuming and negative outcomes could result in liability for monetary damages, including treble damages and attorneys’
fees if we are found to have willfully infringed a patent. There is also no guarantee that we would be able to obtain a license under
such infringed intellectual property on commercially reasonable terms or at all. A finding of infringement could prevent us or our collaborators
from developing, marketing or selling a product candidate or force us to cease some or all of our business operations. Even if we are
successful in these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel
may be diverted as a result of these proceedings, which could have a material adverse effect on us. Claims that we have misappropriated
the confidential information or trade secrets of third parties could similarly have a negative impact on our business.
We may be required to pay royalties to employees
who develop inventions that have been or will be commercialized by us, even if the rights to such inventions have been assigned to us
and the employees have waived their rights to royalties or other additional compensation.
A significant portion of our intellectual property has been developed
by our employees in the course of their employment for us. Under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived
by an employee in the course and as a result of or arising from his or her employment with a company are regarded as “service inventions,”
which belong to the employer, absent a specific agreement between the employee and employer giving the employee proprietary rights. The
Patent Law also provides under Section 134 that if there is no agreement between an employer and an employee as to whether the employee
is entitled to consideration for service inventions, and to what extent and under which conditions, the Israeli Compensation and Royalties
Committee, or the Committee, a body constituted under the Patent Law, shall determine these issues. Section 135 of the Patent Law provides
criteria for assisting the Committee in making its decisions. According to the decisions of the Committee, an employee’s right to
receive consideration for service inventions is a personal right and is entirely separate from the proprietary rights in such invention.
Therefore, this right must be explicitly waived by the employee. A decision handed down in May 2014 by the Committee clarifies that the
right to receive consideration under Section 134 can be waived and that such waiver can be made orally, in writing or by behavior like
any other contract. The Committee will examine, on a case by case basis, the general contractual framework between the parties, using
interpretation rules of the general Israeli contract laws. Further, the Committee has not yet determined one specific formula for calculating
this remuneration, nor the criteria or circumstances under which an employee’s waiver of his right to remuneration will be disregarded.
Similarly, it remains unclear whether waivers by employees in their employment agreements of the alleged right to receive consideration
for service inventions should be declared as void being a depriving provision in a standard contract. All of our employees execute invention
assignment agreements upon commencement of employment, in which they assign their rights to potential inventions and acknowledge that
they will not be entitled to additional compensation or royalties from commercialization of inventions. Although our employees have agreed
to assign to us service invention rights and have specifically waived their right to receive any special remuneration for such service
inventions beyond their regular salary and benefits, we may face claims demanding remuneration in consideration for assigned inventions.
Changes in U.S. patent law could diminish the
value of patents in general, thereby impairing our ability to protect our product candidates.
As is the case with other biotechnology companies, our success
is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing biotechnology patents involves technological
and legal complexity, and is costly, time consuming, and inherently uncertain. In addition, the U.S. Supreme Court has ruled on several
patent cases, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners
in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination
of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the
federal courts, and the U.S. Patent and Trademark Office, the laws and regulations governing patents could change in unpredictable ways
that may weaken or undermine our ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future.
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Our employment agreements with our employees
and other agreements with our collaborators and third parties may not adequately prevent disclosure of trade secrets, know-how and other
proprietary information.
A substantial portion of our technologies and intellectual property
is protected by trade secret laws. We rely on a combination of patent and other intellectual property laws as well as our employment agreements
with our employees and other agreements with our collaborators and third parties to protect and otherwise seek to control access to, and
distribution of, our proprietary information. These measures may not prevent disclosure, infringement or misappropriation of our confidential
information. Our confidentiality, nondisclosure and assignment agreements or covenants may be breached, and we may not have adequate remedies
for such a breach that would effectively prevent the further dissemination of our confidential information. We have limited control over
the protection of trade secrets used by our collaborators and unauthorized disclosure might occur. In addition, others may independently
discover our trade secrets and proprietary information, and in such cases we could not assert any trade secret rights against such parties.
Laws regarding trade secret rights in certain markets where we operate may afford little or no protection of our trade secrets. Failure
to obtain or maintain trade secret protection could adversely affect our business, sales and competitive position.
We may not be able to fully enforce covenants
not to compete with our key employees, and therefore we may be unable to prevent our competitors from benefiting from the expertise of
such employees.
Our employment agreements with key employees, which include executive
officers, contain non-compete provisions. These provisions prohibit our key employees, if they cease working for us, from competing directly
with us or working for our competitors for one year. Under applicable U.S. and Israeli laws, we may be unable to enforce these provisions.
If we cannot enforce the non-compete provisions with our key employees, we may be unable to prevent our competitors from benefiting from
the expertise of such employees. Even if these provisions are enforceable, they may not adequately protect our interests. The defection
of one or more of our employees to a competitor could materially adversely affect our business, results of operations and ability to capitalize
on our proprietary information.
Risks Relating to Our Incorporation and Location in Israel
Conditions in Israel, including Israel’s
conflicts with Hamas and other parties in the region, as well as political and economic instability, may adversely affect our operations
and limit our ability to market our products, which would lead to a decrease in revenues.
We are incorporated under Israeli law, and our employees, including
our Chief Executive Officer, our Chief Financial Officer, and other senior members of our management team, operate from our headquarters
located in Israel. In addition, the majority of our directors are residents of Israel. Accordingly, our business and operations are directly
affected by economic, political, geopolitical, and military conditions in Israel.
Since the establishment of the State of Israel in 1948 and in recent
years, armed conflicts between Israel and its neighboring countries and terrorist organizations active in the region have involved missile
strikes, hostile infiltrations, abduction of soldiers and citizens, and terrorism against civilian targets in various parts of Israel.
Israel was engaged in a war with Hamas, a terrorist organization
based in the Gaza Strip on Israel’s southern border, from October 7, 2023 until October 2025, when a U.S.-brokered ceasefire took
effect. Israeli forces remain deployed in parts of the Gaza Strip, and the situation remains volatile. Similarly, Israel was engaged in
a military conflict with Hezbollah, a terrorist organization based in Lebanon on Israel’s northern border, which ended with a ceasefire
in November 2024. Each such terrorist group has been sponsored by Iran. Iran itself directly entered the conflict, launching ballistic
missile attacks against Israel in April 2024 and October 2024. In June 2025, following intelligence assessments indicating imminent attacks,
Israel conducted strikes against Iranian military and nuclear infrastructure, which led to Iranian counterattacks before a ceasefire was
reached after 12 days of hostilities. On February 28, 2026, Israel and the United States launched a second, larger-scale offensive against
Iran. Iran has retaliated with sustained attacks across the Middle East and was joined by renewed Hezbollah attacks on Israel. As of the
date of this filing, the conflict is ongoing with no ceasefire in place and the situation remains volatile, with the potential for escalation
into a broader regional conflict involving additional terrorist organizations and possibly other countries. Other Iranian-sponsored
terrorist organizations in the Middle East, including the Houthi terrorist militia in Yemen, also launched aerial strikes against Israel
during the two-year war period.
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While our facilities have not been damaged during the current war,
the hostilities with Hamas, Hezbollah, Iran and its proxies and others have caused and may continue to cause damage to private and public
facilities, infrastructure, utilities, and telecommunication networks, and potentially disrupting our operations. In addition, Israeli
organizations, government agencies and companies have been subject to extensive cyber-attacks. This could lead to increased costs, risks
to employee safety, and challenges to business continuity, with potential financial losses.
The continuation of the war has also led to a deterioration of
certain indicators of Israel’s economic standing, for instance, a downgrade in Israel’s credit rating by rating agencies (such
as by Moody’s, S&P Global, and Fitch). As of the date of this Annual Report, Moody’s and S&P Global have revised their
respective credit outlooks on Israel from “negative” to “stable.”
In connection with the ongoing war, several hundred thousand Israeli
military reservists were drafted to perform immediate military service, and military reservists are expected to perform long reserve duty
service in the coming years. As of the date of this Annual Report, only several of our employees have been called to active military duty.
The absence of our employees due to their military service in the current or future wars or other armed conflicts may materially and adversely
affect our ability to conduct our operations.
Our commercial insurance does not cover losses that may occur as
a result of events associated with war and terrorism. Although the Israeli government currently covers the reinstatement value of certain
direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that such government coverage will be maintained
or that it will sufficiently cover our potential damages. Any losses or damages incurred by us could have a material adverse effect on
our business.
The global perception of Israel and Israeli companies, influenced
by actions by international judicial bodies, may lead to increased sanctions and other negative measures against Israel, as well as Israeli
companies and academic institutions. There is also a growing movement among countries, activists, and organizations to boycott Israeli
goods, services and academic research or restrict business with Israel, which could affect business operations. If these efforts become
widespread, along with any future rulings from international tribunals against Israel, they could significantly and negatively impact
business operations.
Exchange rate fluctuations between the U.S.
dollar and the NIS may negatively affect our financial results.
The Company’s reporting currency is U.S. dollars. In view
of the fact that a substantial part of our expenses is in NIS, any appreciation of the NIS relative to the U.S. dollar would adversely
impact our financial results. The appreciation (devaluation) of the NIS in relation to the U.S. dollar amounted to 12.5%, (0.6%) and (3.1%)
as of December 31, 2025, 2024 and 2023, respectively. These fluctuations could cause our results of operations to differ from our expectations
or the expectations of our investors. Additionally, such foreign currency exchange rate fluctuations could make it more difficult to detect
underlying trends in our business and results of operations. As of the data of this Annual Report, we do not maintain a program to
hedge transactional exposures in certain foreign currencies. If we enter into hedging contracts in the future, we may be unsuccessful
in protecting against currency exchange rate fluctuations. See “Item 11. Quantitative and Qualitative Disclosure About Market Risk—Foreign
Currency Risk.”
We also cannot predict any future trends in the rate of inflation
or deflation in Israel. The Israeli annual rate of inflation amounted to 3.0%, 3.2% and 2.6% for the years ended December 31, 2023, 2024
and 2025, respectively.
Interest rate fluctuations may devalue our
investments and could have an adverse impact on our financial condition.
From time to time we hold corporate bonds and government treasury
notes denominated in NIS and in U.S. dollars. These investments expose us to the risk of interest rate fluctuations. A decrease in Israeli
or in U.S. interest rates could cause the fair value of these investments to decrease.
29
We received Israeli government grants for certain
of our research and development activities as detailed below. The terms of those grants require us to satisfy specified conditions in
order to transfer outside of Israel the manufacture of products based on know-how funded by the Israeli Innovation Authority or to transfer
outside of Israel the know-how itself. If we fail to comply with the requirements of Israeli Law in this regard, we may be required to
pay penalties, and it may impair our ability to sell our technology outside of Israel.
Our research and development operations have been partly financed
through certain governmental grants. Certain of these grants are royalty-bearing grants under the terms of which we are committed
to pay royalties at a rate of 3.0% - 4.0% on sales proceeds from our products that were developed under Israeli Innovation Authority,
or the IIA, programs up to the total amount of grants received, plus accrued interest, linked to the U.S. dollar. Pursuant to the latest
IIA regulations, grants received from the IIA before June 20, 2017, bear an annual interest rate that applied at the time of the approval
of the applicable file and such interest will apply to all funding received under that approval. Grants received from the IIA after June
30, 2017, bear an annual interest rate based on the 12-month London Interbank Offered Rate, until December 31, 2023, and as of January
1, 2024, bear an annual interest rate based on the 12-month Secured Overnight Financing Rate, or SOFR, or at an alternative rate published
by the Bank of Israel plus 0.71513%. Grants approved after January 1, 2024, bear the higher of 12 months SOFR interest plus 1% or a fixed
annual interest rate of 4%.
In addition, these IIA grants impose certain restrictions on the
transfer outside of Israel of the underlying know-how and the manufacturing or manufacturing rights of the underlying products and technologies.
As of December 31, 2025, we had received from the IIA approximately $9.6 million (including accrued interest) of royalty-bearing grants,
and repaid approximately $4.4 million in royalties and an additional approximately $4.9 million from the IIA in respect of several non-
royalty-bearing projects. We may not receive the required approvals should we wish to transfer the know-how, technology or manufacturing
rights related to such government grants outside of Israel in the future or, if we receive such required approvals, they may be subject
to certain conditions and payment obligations. See “Item 5. Operating and Financial Review and Prospects—B. Liquidity and
Capital Resources—Government Grants.”
If we incorporate new subsidiaries, the IIA may deem that any such
new subsidiary is a co-beneficiary of the Company, such that the new subsidiary is liable to the IIA, severally and jointly with the Company,
for all amounts which may be due to the IIA in connection with previously received grants. Such a perception might be burdensome with
respect to incorporation of new subsidiaries and new projects.
It may be difficult to enforce a U.S. judgment
against us, our officers and directors and the Israeli experts named in this Annual Report in Israel or the United States, or to assert
U.S. securities laws claims in Israel or serve process on our officers and directors and these experts.
We are incorporated in Israel. The majority of our directors and
executive officers reside outside the United States and the majority of our assets are located outside the United States. Therefore, it
may be difficult for an investor, or any other person or entity, to enforce a U.S. court judgment based upon the civil liability provisions
of the U.S. federal securities laws against us or any of these persons in a U.S. or Israeli court, or to effect service of process upon
these persons in the United States. Additionally, it may be difficult for an investor, or any other person or entity, to assert U.S. securities
law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities
laws on the grounds that Israel is not the most appropriate forum in which to bring such a claim. Even if an Israeli court agrees to hear
a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content
of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also
be governed by Israeli law. There is little binding case law in Israel addressing the matters described above.
Your rights and responsibilities as our shareholder
will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.
Since we are incorporated under Israeli law, the rights and responsibilities
of our shareholders are governed by Israeli law and by our articles of association. These rights and responsibilities differ in some respects
from the rights and responsibilities of shareholders of U.S.-based corporations. In particular, a shareholder of an Israeli company has
a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and
other shareholders and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting
of shareholders on certain matters, such as an amendment to the company’s articles of association, an increase of the company’s
authorized share capital, a merger of the company and approval of related party transactions that require shareholder approval. A shareholder
also has a general duty to refrain from discriminating against other shareholders. In addition, a controlling shareholder or a shareholder
who knows that it possesses the power to determine the outcome of a shareholders’ vote or to appoint or prevent the appointment
of an office holder in the company has a duty to act in fairness towards the company. However, Israeli law does not define the substance
of this duty of fairness. There is limited case law available to assist us in understanding the nature of this duty or the implications
of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our ordinary shares
that are not typically imposed on shareholders of U.S. corporations. See “Item 6. Directors, Senior Management and Employees—C.
Board Practices—Shareholder Duties.”
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Provisions of Israeli law may delay, prevent
or make undesirable an acquisition of all or a significant portion of our shares or assets.
Certain provisions of Israeli law and our articles of association
could have the effect of delaying or preventing a change in control and may make it more difficult for a third party to acquire us or
for our shareholders to elect different individuals to our board of directors, even if doing so would be beneficial to our shareholders,
and may limit the price that investors may be willing to pay in the future for our ordinary shares. For example, Israeli corporate law
regulates mergers and requires that a tender offer be effected when certain thresholds of percentage ownership of voting power in a company
are exceeded (subject to certain conditions). Further, Israeli tax considerations may make potential transactions undesirable to us or
to some of our shareholders whose country of residence does not have a tax treaty with Israel granting tax relief to such shareholders
from Israeli tax. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent
on the fulfillment of numerous conditions, including a holding period of two years from the date of the transaction during which certain
sales and dispositions of shares of the participating companies are restricted. Moreover, with respect to certain share swap transactions,
the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no actual disposition of the shares has
occurred. See Exhibit 2.1 to this Annual Report.
Furthermore, under the Israeli Encouragement of Research, Development
and Technological Innovation in the Industry Law, 5744-1984 (formerly known as the Law for the Encouragement of Research and Development
in Industry 5744-1984), and the regulations, guidelines, rules, procedures and benefit tracks thereunder, collectively, the Innovation
Law, to which we are subject due to our receipt of grants from the IIA, a recipient of IIA grants such as our company must report to the
IIA regarding any change in the holding of any means of control of our company. If following such change any non-Israeli citizen or resident
becomes an “interested party”, as defined in the Israeli Securities Law 5728-1968, such non-Israeli citizen or resident shall
execute an undertaking in favor of IIA, in a form prescribed by IIA.
Risks Related to Our Ordinary Shares and the Ownership and Trading
of Our Ordinary Shares
The price of our ordinary shares may fluctuate
significantly. Further, there is no guarantee of a continuing public market to resell our ordinary shares.
The market price of our ordinary shares could be highly volatile
and may fluctuate substantially as a result of many factors, including:
▪ our inability to obtain additional funding;
▪ any delay in filing a regulatory submission for any of our product or product candidates and any adverse development or perceived adverse development with respect to the review of that regulatory submission by the applicable regulatory body;
▪ actual or anticipated fluctuations in our results of operations;
▪ variance in our financial performance from the expectations of market analysts;
▪ announcements by us or our competitors of significant business developments, changes in relationships with our collaborators, acquisitions or expansion plans;
▪ our involvement in litigation;
▪ our sale, or the sale by our significant shareholders, of ordinary shares or other securities in the future;
▪ failure to publish research or the publishing of inaccurate or unfavorable research;
▪ market conditions in our industry and changes in estimates of the future size and growth rate of our markets;
▪ changes in key personnel;
▪ the trading volume of our ordinary shares; and
▪ general economic and market conditions, including as a result of the scope and duration of the war in Israel.
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Although our ordinary shares are listed on Nasdaq, an active trading
market on Nasdaq for our ordinary shares may not be sustained. If an active market for our ordinary shares is not sustained, it may be
difficult to sell ordinary shares in the U.S.
In addition, the stock market in general, and the Nasdaq and the
market for biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated
or disproportionate to the operating performance of companies like ours. Broad market and industry factors may materially harm the market
price of our ordinary shares, regardless of our operating performance. Further, a systemic decline in the financial markets and related
factors beyond our control may cause our share price to decline rapidly and unexpectedly. Price volatility of our ordinary shares might
be worse if the trading volume of our ordinary shares is low. In the past, following periods of volatility in the market price of a company’s
securities, securities class action litigation has often been instituted against that company. If we were involved in any similar litigation,
we could incur substantial costs and our management’s attention and resources could be diverted.
Any inability to meet the Nasdaq listing requirements
may have an adverse effect on our share price and lead to our delisting from Nasdaq.
We are required to meet the continued listing requirements of Nasdaq,
including those regarding minimum share price. In particular, we are required to maintain a minimum bid price for our listed ordinary
shares of $1.00 per share. On October 31, 2022, we received a written notification from Nasdaq, which stated that because the closing
bid price of our ordinary shares for 31 consecutive business days was below the minimum $1.00 per share bid price requirement for continued
listing on the Nasdaq Capital Market, we were not in compliance with Nasdaq Listing Rule 5550(a)(2). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A),
the applicable grace period to regain compliance was 180 days, or until May 1, 2023. On July 17, 2023, we announced that Nasdaq confirmed
that we had regained compliance with Nasdaq Listing Rule 5550(a)(2) concerning the minimum bid price of our ordinary shares.
On September 18, 2023, we received another written notification
from Nasdaq, which stated that because the closing bid price of our ordinary shares for 30 consecutive business days was below the minimum
$1.00 per share bid price requirement for continued listing on the Nasdaq Capital Market, we were not in compliance with Nasdaq Listing
Rule 5550(a)(2).
In an effort to regain compliance with these rules, on July 24,
2024, we effected a reverse share split of our ordinary shares at the ratio of 1-for-10, such that each ten (10) ordinary shares, par
value NIS 0.02 per share, have been consolidated into one (1) ordinary share, par value NIS 0.2 per share. While this action temporarily
brought us into compliance, there is no guarantee that we will be able to sustain the minimum bid price or other listing standards in
the future. Reverse share splits do not necessarily result in sustained market price improvements and can lead to a decrease in our overall
market capitalization if the trading price of our shares declines. As of March 12, 2026, the trading price for our ordinary shares was
again below $1.00 per share, with a closing price of $0.94 as of such date.
On January 17, 2025, the SEC approved an amendment to Nasdaq Listing
Rule 5810(c)(3)(A)(iv), according to which, if a company fails to meet the minimum bid price requirement and the company has effected
a reverse share split over the prior one-year period, the company would not be eligible for any compliance period and the Listing Qualifications
Department will issue a Delisting Determination under Nasdaq Listing Rule 5810 with respect to that company’s securities. This change
will apply to a company even if the company was in compliance with the bid price requirement at the time of its prior reverse share split.
In addition, if a company’s security fails to meet the bid price requirement and the company has effected one or more reverse stock
splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, then the company is not eligible for any compliance
periods and Nasdaq must issue a Delisting Determination with respect to that security. Accordingly, there is a risk that if we effect
reverse share splits, and our ordinary shares continue to trade below $1.00 per share for 30 consecutive business days, we will not be
eligible for any compliance period and the Listing Qualifications Department will issue a Delisting Determination for our ordinary shares
by Nasdaq.
There are numerous factors and contingencies that have affected
our price following the reverse split, including the status of the market for our ordinary shares, our reported results of operations
and general economic, market and industry conditions. The market price of our ordinary shares has decline since the reverse split and
may not return to the direct arithmetic result of the reverse split. If the market price of our ordinary shares continues to decline,
our total market capitalization (the aggregate value of all of our outstanding ordinary shares at the then existing market price) after
the reverse split will remain lower than before the reverse split. In addition, the reverse split resulted
in some shareholders owning “odd lots” of less than 100 ordinary shares on a post-split basis. Odd lots may be more difficult
to sell, or require greater transaction costs per share to sell, than shares in “round lots” of even multiples of 100 shares.
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In the event that our ordinary shares are delisted from Nasdaq
due to our failure to continue to comply with the requirements for continued listing on Nasdaq, and are not eligible for listing on another national
securities exchange, trading in our ordinary shares could be conducted in the over-the-counter market or on an electronic bulletin board
established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to
dispose of, or obtain accurate price quotations for, our Ordinary Shares, and it would likely be more difficult to obtain coverage by
securities analysts and the news media, which could cause the price of our ordinary shares to decline further. Also, it may be difficult
for us to raise additional capital if we are not listed on a national exchange and we could suffer reputational damage and diminished
investor, supplier and employee confidence.
Our ordinary shares are traded on more than
one market and this may result in price variations.
Our ordinary shares are listed on both the TASE and Nasdaq. Trading
in our ordinary shares on these markets takes place in different currencies (U.S. dollars on Nasdaq and NIS on the TASE), and at different
times (resulting from different time zones, trading days and public holidays in the United States and Israel). The trading prices of our
ordinary shares on these two markets may differ due to these and other factors. Any decrease in the price of our ordinary shares on the
TASE could cause a decrease in the trading price of our ordinary shares on Nasdaq or vice versa.
We could become subject to parallel reporting
obligations in Israel and the United States, which could increase compliance costs and divert management attention.
We currently solely utilize U.S. reporting standards under the
rules and regulations of the SEC. However, should this change in the future, we may become subject to parallel reporting obligations in
Israel and the United States. While similar in many respects, certain differences between Israeli and U.S. reporting schemes may impose
on us disclosure obligations that are more stringent than those generally applied to foreign private issuers whose securities are listed
only in the United States. In addition, a requirement to comply with the separate reporting obligations under U.S. and Israeli securities
laws would require additional management attention and could burden us with additional costs.
The requirements of being a public company
in the United States and Israel may strain our resources and distract our management, which could make it difficult to manage our business.
Changing laws, regulations and standards, in the United States
or Israel, relating to corporate governance and public disclosure and other matters, may be implemented in the future, which may increase
our legal and financial compliance costs, make some activities more time consuming and divert management’s time and attention from
revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ
from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate
legal proceedings against us and our business may be harmed. Being a publicly traded company in the United States and Israel and being
subject to U.S. and Israeli rules and regulations make it more expensive for us to obtain D&O insurance, and we may be required to
accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us
to attract and retain qualified members of our board of directors, particularly to serve on our audit committee, and qualified executive
officers.
As a public company whose ordinary shares are listed in the United
States, we will continue to incur significant accounting, legal and other expenses, including costs associated with our reporting requirements
under the Exchange Act. We also incur additional costs associated with corporate governance requirements, including requirements under
Section 404 and other provisions of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, rules implemented by the SEC and the Nasdaq,
and provisions of Israeli corporate and securities laws applicable to public companies. The Exchange Act requires that we file annual
and certain other reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires, among other things, that
we maintain effective disclosure controls and procedures and internal control over financial reporting. These rules and regulations could
continue to increase our legal and financial compliance costs, such as the cost of hiring consultants or testing compliance processes,
and make some activities more time-consuming and costly. These activities may divert management’s attention from other business
concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
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As a foreign private issuer we are not subject
to the provisions of Regulation FD or U.S. proxy rules and are exempt from filing certain Exchange Act reports.
As a foreign private issuer, we are exempt from compliance with
the rules and regulations under the Exchange Act related to the furnishing and content of proxy statements. Our principal shareholders
continue to remain exempt from the reporting under Section 16(a) of the Exchange Act and our directors, officers and principal shareholders
continue to remain exempt from the short-swing profit recovery provisions contained in Section 16(b) of the Exchange Act. In addition,
we are not required under the Exchange Act to file annual and certain other reports and financial statements with the SEC as frequently
or as promptly as U.S. domestic companies whose securities are registered under the Exchange Act, we are permitted to disclose limited
compensation information for our executive officers on an individual basis and we are generally exempt from filing quarterly reports with
the SEC under the Exchange Act. Moreover, we are not required to comply with Regulation FD, which restricts the selective disclosure of
material nonpublic information to, among others, broker-dealers and holders of a company’s securities under circumstances in which
it is reasonably foreseeable that the holder will trade in the company’s securities on the basis of the information. These
exemptions and leniencies will reduce the frequency and scope of information and protections to which you may otherwise have been eligible
in relation to a U.S. domestic issuer.
As a foreign private issuer, we have elected
to follow home country corporate governance practices instead of certain Nasdaq corporate governance requirements, which may result in
less protection than is accorded to investors under rules applicable to domestic U.S. issuers.
As a foreign private issuer whose shares are listed on the Nasdaq
Capital Market, we are permitted to follow certain home country corporate governance practices instead of those otherwise required under
the corporate governance standards for U.S. domestic issuers listed on Nasdaq. We currently follow Israeli home country practices, rather
than the requirements under the Nasdaq corporate governance rules, with regard to the (i) quorum requirement for shareholder meetings,
(ii) executive sessions for independent directors and non-management directors and (iii) the requirements to obtain shareholder approval
for certain dilutive events (such as for the establishment or amendment of certain equity-based compensation plans, issuances that will
result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest
in the company and certain acquisitions of the stock or assets of another company). See “Item 16G. Corporate Governance.”
Furthermore, we may in the future elect to follow Israeli home country practices with regard to other matters such as the requirement
to have a majority independent board of directors, have a compensation committee and have a nominating committee. Accordingly, our shareholders
may not be afforded the same protection as provided under Nasdaq corporate governance rules. Following our home country governance practices
as opposed to the requirements that would otherwise apply to a United States company listed on Nasdaq may provide less protection than
is accorded to investors of domestic issuers. For further discussion, see “Item 16G. Corporate Governance.”
We may lose our status as a foreign private
issuer, which would increase our compliance costs and could thereby negatively impact our results of operations.
We would lose our foreign private issuer status if (a) a majority
of our outstanding voting securities were either directly or indirectly owned of record by residents of the United States and (b)(i) a
majority of our executive officers or directors were United States citizens or residents, (ii) more than 50 percent of our assets were
located in the United States, or (iii) our business were administered principally outside the United States. Our loss of foreign private
issuer status would make U.S. regulatory provisions mandatory. The regulatory and compliance costs to us under U.S. securities laws as
a U.S. domestic issuer may be significantly higher. If we are not a foreign private issuer, we will be required to file periodic reports
and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive than the forms available
to a foreign private issuer. We would also be required to follow U.S. proxy disclosure requirements, including the requirement to disclose,
under U.S. law, more detailed information about the compensation of our senior executive officers on an individual basis. We may also
be required to modify certain of our policies to comply with accepted governance practices associated with U.S. domestic issuers. Such
conversion and modifications will involve additional costs. In addition, we would lose our ability to rely upon exemptions from certain
corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers, as described in the previous
risk factor above.
If a United States person is treated as owning
at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
If a United States person is treated as owning (directly, indirectly
or constructively) at least 10% of the value or voting power of our ordinary shares, such person may be treated as a “United States
shareholder” with respect to each “controlled foreign corporation” in our group (if any). If our group includes one
or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as controlled foreign corporations (regardless of whether
we are or are not treated as a controlled foreign corporation). A United States shareholder of a controlled foreign corporation may be
required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income”, “global
intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, whether or not we make any distributions.
An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain
tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. A failure to comply
with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect
to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we
will assist investors in determining whether any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether
such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations or furnish to any
United States shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations. A
United States investor should consult their own advisors regarding the potential application of these rules to its investment in the ordinary
shares.
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We believe we were a PFIC for U.S. federal
income tax purposes in 2025, and there is risk we will be a PFIC in 2026. U.S. shareholders who held our ordinary shares at any
time during a taxable year in which we are a PFIC may suffer adverse tax consequences.
Generally, if for any taxable year 75% or more of our gross income
is passive income, or at least 50% of the average quarterly value of our assets (which may be determined in part by the market value of
our ordinary shares, which is subject to change) are held for the production of, or produce, passive income, we would be characterized
as a PFIC for United States federal income tax purposes. According to these rules, a publicly traded non-U.S. corporation may treat the
aggregate fair market value of its assets as being equal to the sum of the aggregate value of its outstanding shares, or Market Capitalization,
and the total amount of its liabilities. We intend to take the position that the excess of our Market Capitalization plus liabilities
over the book value of all of our assets may generally be treated as attributable to non-passive assets. Based on the book value of our
assets and liabilities and our Market Capitalization in 2025, we believe that we met the PFIC asset test described above for 2025. Because
we currently hold, and expect to continue to hold, a substantial amount of cash and cash equivalents and other passive assets used in
our business, there is risk we will be classified as a PFIC for the 2026 taxable year. However, because PFIC status is determined after
the close of each taxable year, we will not be able to determine whether we will be a PFIC for the 2026 taxable year or for any future
taxable year until after the close of such year.
U.S. shareholders who held our ordinary shares during any other
taxable year in which we were a PFIC may suffer adverse tax consequences, including having gains realized on the sale of our ordinary
shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on our
ordinary shares by individuals who are U.S. Holders (as defined in “Item 10. Additional Information—E. Taxation—United
States Federal Income Taxation”), and having interest charges apply to distributions by us and the proceeds of share sales. Certain
elections may be available that would alleviate some of the adverse consequences of PFIC status and result in an alternative treatment
(such as mark-to-market treatment) of our ordinary shares; however, we do not intend to provide the information necessary for U.S. holders
to make qualified electing fund elections. See “Item 10. Additional Information—E. Taxation—United States Federal Income
Taxation—Passive Foreign Investment Company Considerations.”
General Risk Factors
If we fail to maintain effective
internal control over financial reporting, the price of our ordinary shares may be adversely affected.
Our internal control over financial reporting may have weaknesses
and conditions that could require correction or remediation, the disclosure of which may have an adverse impact on the price of our ordinary
shares. We are required to establish and maintain appropriate internal control over financial reporting. Failure to establish
those controls, or any failure of those controls once established, could adversely affect our public disclosures regarding our business,
prospects, financial condition or results of operations. In addition, management’s assessment of internal control over financial
reporting may identify weaknesses and conditions that need to be addressed in our internal control over financial reporting or other matters
that may raise concerns for investors. In addition, as a “non-accelerated filer,” we are exempt from the provisions
of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report
on the effectiveness of internal control over financial reporting. Decreased disclosures in our SEC filings due to our status
as a “non-accelerated filer” may make it harder for investors to analyze our results of operations and financial prospects
and may make our ordinary shares a less attractive investment. Any actual or perceived weaknesses and conditions that need to be addressed
in our internal control over financial reporting or disclosure of management’s assessment of our internal control over financial
reporting may have an adverse impact on the price of our ordinary shares.
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