What changed in this filing

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Item 1A. Risk Factors

2025-03-25 compared with 2024-04-04 · 953 added, 932 removed, 1279 unchanged (60% of the section changed)

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Risks Related to Our Business, Technology and Industry

We are a clinical-stage company with limited operating history

and have incurred losses since our inception.

We anticipate that we will continue to incur significant expenses, and we will continue

to incur significant losses for the foreseeable future.

We are a clinical-stage biopharmaceutical company with limited operating

We have incurred losses in each year since BiomX Ltd.’s inception in 2015.

As of December 31, 2023, our accumulated deficit

was $163 million, and we expect to incur increasingly significant losses for the foreseeable future.

Preclinical development and clinical

trials and activities are costly.

We have devoted, and will continue to devote for the foreseeable future, substantially all of our resources

to research and development and clinical trials for our product candidates.

We do not expect to generate any revenue from the commercial

sales of our product candidates in the near term.

In addition, as a result of the Acquisition, our future business, prospects, financial

position and operating results could be significantly different than those in historical periods or projected by our management.

We are a clinical-stage company and have incurred losses since

our inception.

We anticipate that we will continue to incur significant expenses, and we will continue to incur significant losses for

the foreseeable future.

We are a clinical-stage biopharmaceutical company

with limited operating history compared to the long time it takes to develop phage based products.

We have incurred losses in each year

since BiomX Ltd.’s inception in 2015.

As of December 31, 2024, our accumulated deficit was $180.7 million, and we expect to incur

increasingly significant losses for the foreseeable future.

Preclinical development and clinical trials and activities are costly.

have devoted, and will continue to devote for the foreseeable future, substantially all of our resources to research and development

and clinical trials for our product candidates.

We do not expect to generate any revenue from the commercial sales of our product candidates

in the near term.

In addition, as a result of the Acquisition, our future business, prospects, financial position and operating results

could be significantly different than those in historical periods or projected by our management.

For the years ended December 31, 2024 and 2023,

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We anticipate that the level of our expenses is expected

to increase as a result of the recent acquisition of APT, and will continue to be significant if and as we:

initiate and continue research, preclinical and clinical development efforts for any future product candidates;

seek to discover and develop additional product candidates and further expand our clinical product pipeline;

seek marketing and regulatory approvals for any product candidates that successfully complete clinical trials;

require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization;

maintain, expand and protect our intellectual property portfolio;

expand our research and development infrastructure, including hiring and retaining additional personnel, such as clinical, quality control and scientific personnel;

establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize products for which we obtain marketing approval, if any;

add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization and help us comply with our obligations as a public company.

to increase and will continue to be significant if and as we:

initiate and continue research, preclinical and clinical

development efforts for any future product candidates;

seek to discover and develop additional product candidates

and further expand our clinical product pipeline;

seek marketing and regulatory approvals for any product

candidates that successfully complete clinical trials;

require the manufacture of larger quantities of product

candidates for clinical development and, potentially, commercialization;

maintain, expand and protect our intellectual property

expand our research and development infrastructure;

establish sales, marketing, distribution and other

commercial infrastructure in the future to commercialize products for which we obtain marketing approval, if any;

add operational, financial and management information

systems and personnel, including personnel to support our product development and commercialization and help us continue to comply

with our obligations as a public company.

We will need to raise additional capital in the future to support

our operations which may not be available at terms that are favorable to us and might cause significant dilution to our stockholders or

increase our debt towards third parties.

our operations which may not be available at terms that are favorable to us and might cause significant dilution to our stockholders

or increase our debt towards third parties.

As of December 31, 2024, we had cash, cash equivalents

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held by us, governmental and other grants and through future equity and debt financing.

In addition, on December 7, 2023, we entered into

an At the Market Offering Agreement, or the ATM Agreement, with H.C.

Wainwright & Co., LLC, or Wainwright, as manager, pursuant to

which we may issue and sell shares of our Common Stock having an aggregate offering price of up to $7.5 million from time to time through

We are not obligated to make any sales of Common Stock under the ATM Agreement.

On May 4, 2023, subsequent to the approval

of the Company’s stockholders, the Company completed the second closing of the February 2023 PIPE for an additional $6 million in

gross proceeds.

On December 7, 2023, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on January

Additionally, on March 15, 2024, concurrently with the consummation of the Acquisition, we consummated a private placement, or

the March 2024 PIPE, pursuant to an exemption from registration requirements under the Securities Act with certain investors pursuant

to which such investors purchased an aggregate of 216,417 shares of our Series X non-voting convertible preferred stock, par value $0.0001

per share, or the Convertible Preferred Stock, and warrants, or Private Placement Warrants, to purchase up to an aggregate of 108,208,500

shares of the Company’s Common Stock, for aggregate gross proceeds of approximately $50 million.

Each share of Convertible Preferred

Stock is convertible into an aggregate of 1,000 shares of Common Stock.

Subject to restrictions pursuant to the March 2024

PIPE, we may continue to sell shares under the ATM Agreement and otherwise to use our shelf registration statement to raise additional

funds from time to time.

We may also raise funds privately, as we did in February 2023 and the March 2024 PIPE.

We may also seek funds

through arrangements with collaborators or others that may require us to relinquish rights to the product candidates that we might otherwise

seek to develop or commercialize independently.

If we enter into a collaboration for one or more

of our current or future product candidates at an earlier development stage, the terms of such a collaboration will likely be less favorable

than if we were to enter the collaboration in later stages or if we commercialized the product independently.

If we raise additional funds

through equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’

rights or cause significant dilution to our stockholders.

If we raise additional capital through debt financing, it would be subject to

fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring

additional debt, making capital expenditures, declaring dividends or acquiring or licensing intellectual property rights.

We have explored and raised funds in multiple

manners since our inception.

For instance we filed in December 2023 a shelf registration statement on Form S-3 that was subsequently

declared effective by the SEC and entered into an At the Market Offering Agreement, or the ATM Agreement, with H.C.

Co., LLC, or Wainwright, as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering

price of up to $7.5 million from time to time through Wainwright.

We are not obligated to make any sales of Common Stock under the ATM

On February 24, 2025, we suspended the ATM Agreement.

Furthermore, on March 15, 2024, concurrently with the consummation of

the Acquisition, we consummated a private placement of $50 million in consideration of 216,417 shares of our Series X non-voting convertible

preferred stock, par value $0.0001 per share, with each such convertible preferred stock being convertible into 100 shares of our shares

of Common Stock and warrants, or Private Placement Warrants, to purchase up to an aggregate of 10,820,850 shares of the Company’s

Common Stock.

Most recently, on February 27, 2025, we completed a registered direct offering and a concurrent private placement.

Additionally,

certain warrant holders agreed to exercise their warrants following our agreement to reduce the exercise price.

Through these transactions,

we generated approximately $12 million in proceeds.

We anticipate conducting additional capital raises in the future.

If we enter into

a collaboration for one or more of our current or future product candidates at an earlier development stage, the terms of such a collaboration

will likely be less favorable than if we were to enter the collaboration in later stages or if we commercialized the product independently.

If we raise additional funds through equity offerings, the terms of these securities may include liquidation or other preferences that

adversely affect our stockholders’ rights or cause significant dilution to our stockholders.

If we raise additional capital through

debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability

to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring or licensing

intellectual property rights.

Developing drugs and conducting clinical trials

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Our future funding requirements will depend on many factors, including:

the costs, timing and progress of our research and development and clinical activities;

manufacturing costs associated with our targeted bacteriophage, or phage, therapies strategy and other research and development activities;

the terms and timing of any collaborative, licensing, acquisition or other arrangements that we may establish;

employee-related expenses, as well as external costs such as fees paid to outside consultants;

the costs and timing of seeking regulatory approvals and related to compliance with regulatory requirements;

the costs of filing, prosecuting, defending and enforcing any patent applications, claims, patents and other intellectual property rights.

the costs, timing and progress of our research and

development and clinical activities;

manufacturing costs associated with our targeted bacteriophage,

or phage, therapies strategy and other research and development activities;

the terms and timing of any collaborative, licensing,

acquisition or other arrangements that we may establish;

employee-related expenses, as well as external costs

such as fees paid to outside consultants;

the costs and timing of seeking regulatory approvals

and related to compliance with regulatory requirements;

the costs of filing, prosecuting, defending and enforcing

any patent applications, claims, patents and other intellectual property rights.

Domestic and international equity and debt markets

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and concerns.

In the event these economic conditions and concerns continue or worsen and the markets continue to remain volatile, or a

bear market, or recession, ensues in the U.S.

stock market, or the markets are negatively impacted by factors such as the Israel-Hamas

War, the Russian invasion of Ukraine and the resulting world sanctions on Russia, Belarus, and related parties or other sources of geopolitical

uncertainty and instability, our operating results and liquidity could be affected adversely by those factors in many ways, including

making it more difficult for us to raise funds if necessary and our stock price may decline.

In the event these economic conditions and concerns continue or worsen and the markets continue to remain volatile, or

a bear market, or recession, ensues in the U.S.

stock market, or the markets are negatively impacted by factors such as Israel’s

war with Hamas and Hezbollah, the Russian invasion of Ukraine and the resulting world sanctions on Russia, Belarus, and related parties

or other sources of geopolitical uncertainty and instability, our operating results and liquidity could be affected adversely by those

factors in many ways, including making it more difficult for us to raise funds if necessary and our stock price may decline.

There can be no assurance that sufficient funds

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adverse effect on our business, financial condition and results of operations.

Moreover, if we are unable to obtain additional funds on

a timely basis, there will be substantial doubt about our ability to continue as a going concern and increased risk of insolvency and

up to a total loss of investment by our stockholders.

Moreover, if we are unable to obtain additional funds

on a timely basis, there will be substantial doubt about our ability to continue as a going concern and increased risk of insolvency

and up to a total loss of investment by our stockholders.

Our financial statements contain an explanatory paragraph regarding

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terms or at all.

Our financial statements contain

an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

We have concluded that there is

substantial doubt about our ability to continue as a going concern.

We have accumulated a deficit of $163 million since our inception.

To date, we have not generated revenue from our operations and we do not expect to generate any significant revenues from sales of products

in the next twelve months.

Our financial statements

contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

We have concluded that

there is substantial doubt about our ability to continue as a going concern.

We have accumulated a deficit of $180.7 million since our

To date, we have not generated revenue from our operations and we do not expect to generate any significant revenues from

sales of products in the next twelve months.

Our cash needs may increase in the foreseeable future.

As of December 31, 2023, we had $15.9 million of cash

and cash equivalents.

We believe our cash and cash equivalents and short-term

deposits on hand will be sufficient to meet our working capital and capital expenditure requirements for at least 12 months.

since there is a risk of our stockholders not approving the conversion of the Convertible Preferred Stock that was issued in connection

with the March 2024 PIPE and the Acquisition, which could result in us being required to cash settle the Convertible Preferred Stock,

there is substantial doubt about our ability to continue as a going concern for at least 12 months from April 3, 2024.

Our continuation

as a going concern is dependent upon many factors, including our ability to receive the approval of our shareholders to convert the Convertible

Preferred Stock within 5 months, raise additional funds, the success of our clinical trial for CF, our ability to successfully integrate

the business of APT and our ability to repay our obligations when due.

We cannot be sure that we will be able to obtain any future funding,

and any such funding we may obtain may not be sufficient to finance our operations.

If we are unable to obtain sufficient funds, we may

be unable to continue as a going concern.

There is no guarantee that our acquisition

of APT will increase stockholder value.

In March 2024, we acquired APT in the Acquisition.

We cannot guarantee that implementing the Acquisition and related transactions will not impair stockholder value or otherwise adversely

affect our business.

The Acquisition could result in integration challenges between our businesses and management teams which could cause

management and business disruptions, any of which could impact our results of operation and business prospects and impair the value of

such acquisition to our stockholders.

We are required to use reasonable best efforts

to solicit stockholder approval for the conversion of shares of Convertible Preferred Stock and Warrants issued in the Acquisition and

the March 2024 PIPE.

If we do not obtain such approval within 150 days of the initial issuance of the Convertible Preferred Stock, we

could be required to cash settle the Convertible Preferred Stock.

Pursuant to the Merger Agreement, we are required

to hold a meeting of stockholders (the “Stockholder Meeting”) for the purpose of obtaining stockholder approval of (i) the

conversion of the Convertible Preferred Stock and the exercise of the Warrants (as defined below) into shares of Common Stock in excess

of 19.9% of the outstanding shares of Common Stock for purposes of the NYSE American Stock Market Rules, (ii) adoption of a new stock

incentive plan or amendment of the Company’s current stock incentive plan (the “2024 Incentive Plan”), and (iii) if

necessary, the amendment of our certificate of incorporation to authorize sufficient additional shares of Common Stock to allow for conversion

of the Convertible Preferred Stock and exercise of the Warrants.

If such stockholder approval is not received, we are required to convene

additional stockholder meetings at least every 90 days thereafter until such approval is obtained, which could result in substantial costs

and be a distraction to management.

Furthermore, if our stockholders do not approve the conversion of the Convertible Preferred Stock

within 150 days of the initial issuance of the Convertible Preferred Stock, then upon written request by the holders of 70% of the Convertible

Preferred Stock, we will be required to pay to each holder of Convertible Preferred Stock an amount in cash equal to the fair value of

the shares of Convertible Preferred Stock held by such holder, as described in the Certificate of Designation for the Convertible Preferred

We do not expect that we would have sufficient liquidity to settle a significant amount of the Convertible Preferred Stock if required

The cash settlement is not in our control and raises substantial doubt about our ability to continue as a going concern.

As of December 31, 2024, we had $18

million in cash and cash equivalents.

We believe our cash and cash equivalents on hand,

including the cash raised in the February 2025 Financing, as described under “Liquidity and Capital Resources” in Item 7

of this Annual Report, will be sufficient to meet our working capital and capital expenditure requirements into the first quarter of

Our continuation as a going concern is dependent upon many factors, including our ability to raise additional funds, the success

of our clinical trial for CF and DFO and our ability to repay our obligations when due.

We cannot be sure that we will be able to obtain

any future funding, and any such funding we may obtain may not be sufficient to finance our operations.

If we are unable to obtain sufficient

funds, we may be unable to continue as a going concern.

We are seeking to develop product candidates using phage technology,

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no bacteriophage has thus far been approved as a drug in the United States or in the European Union.

We are developing our product candidates with phage

We have not, nor to our knowledge has any other company, received regulatory approval from the FDA, or equivalent foreign

regulatory agencies for a product candidate based on this approach.

While in vitro and in vivo studies have characterized

the behavior of phage in cell cultures and animal models and there exists a body of literature regarding the use of phage therapy in humans,

the safety and efficacy of phage therapy in humans has not been extensively studied in well-controlled modern clinical trials.

the prior research on phage-based therapy was conducted in the former Soviet Union prior to and immediately after World War II and lacked

appropriate control group design or lacked control groups at all.

Furthermore, the standard of care has changed substantially during the

ensuing decades since those studies were performed, diminishing the relevance of prior claims of improved cure rates.

Any product candidates

that we develop may not demonstrate in patients the therapeutic properties ascribed to them in laboratory and other preclinical studies,

and they may interact with human biological systems in unforeseen, ineffective or even harmful ways.

We cannot be certain that our approach

will lead to the development of approvable or marketable products.

Furthermore, the bacterial targets of phage may develop resistance

to our product candidates over time, which we may or may not be able to overcome with the development of new phage cocktails or we may

not be able to construct a cocktail with sufficient coverage of our target pathogen universe.

We are developing our drug product candidates

with phage technology.

We have not, nor to our knowledge has any other company, received regulatory marketing approval from the FDA,

or equivalent foreign regulatory agencies for a drug product based on this approach (phage technology).

While in vitro and in

vivo studies have characterized the behavior of phage in cell cultures and animal models and there exists a body of literature regarding

the use of phage therapy in humans, the safety and efficacy of phage therapy in humans has not been extensively studied in well-controlled

modern clinical trials.

Most of the prior research on phage-based therapy was conducted in the former Soviet Union prior to and immediately

after World War II and lacked appropriate control group design or lacked control groups at all.

Furthermore, the standard of care has

changed substantially during the ensuing decades since those studies were performed, diminishing the relevance of prior claims of improved

Any product candidates that we develop may not demonstrate in patients the therapeutic properties ascribed to them in laboratory

and other preclinical studies, and they may interact with human biological systems in unforeseen, ineffective or even harmful ways.

cannot be certain that our approach will lead to the development of approvable or marketable drug products.

Furthermore, the bacterial

targets of phage may develop resistance to our product candidates over time, which we may or may not be able to overcome with the development

of new phage cocktails or we may not be able to construct a cocktail with sufficient coverage of our target pathogen universe.

If our product candidates receive regulatory approval

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the prevalence and severity of any side effects;

potential advantages or disadvantages over alternative treatments;

potential advantages or disadvantages over alternative

relative convenience and ease of administration;

the strength of marketing and distribution support;

the price of the product, both in absolute terms and relative to alternative treatments;

the price of the product, both in absolute terms and

relative to alternative treatments;

sufficient third-party coverage or reimbursement.

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of the FDA or other regulatory agencies.

Clinical trials of product candidates sufficient to obtain regulatory marketing approval or otherwise

demonstrate safety prior to marketing, are expensive and take years to complete.

Furthermore, results from these clinical trials may not

show safety or efficacy of our product candidates sufficient to lead to approval, or to warrant further development.

Our approach is intended

to design phage combinations, or cocktails, to target specific strains of pathogenic bacteria in order to alter microbiome composition

and confer potential therapeutic or cosmetic benefit to patients.

However, there can be no assurance that the eradication of the selected

targets will result in a clinically meaningful effect on the underlying disease, such as in cases where the pathology of the disease is

not well-defined.

In addition, the bacteria that we target may be associated with the disease, but may not be causative or contributive

to the pathology of the disease, or there may be other bacteria that our product candidates do not target that are more meaningful drivers

of the underlying disease.

In addition, our product candidates require the use of effective delivery vehicles to reach the target organ

or tissue, and there can be no assurance that our intended delivery systems will allow our product candidates to reach the desired locations

in a patient.

Safety must first be established through preclinical testing and early clinical trials, before efficacy can be evaluated

and established and thereby lead to FDA or other regulatory agencies marketing approval.

Our clinical trials may produce undesirable side

effects or negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or preclinical

testing or to abandon programs.

Clinical trials of product candidates sufficient to obtain regulatory marketing approval or

otherwise demonstrate safety prior to marketing, are expensive and take years to complete.

Furthermore, results from these clinical trials

may not show safety or efficacy of our product candidates sufficient to lead to approval, or to warrant further development.

is intended to design phage combinations, or cocktails, to target specific strains of pathogenic bacteria in order to alter microbiome

composition and confer potential therapeutic or cosmetic benefit to patients.

However, there can be no assurance that the eradication

of the selected targets will result in a clinically meaningful effect on the underlying disease, such as in cases where the pathology

of the disease is not well-defined.

In addition, the bacteria that we target may be associated with the disease, but may not be causative

or contributive to the pathology of the disease, or there may be other bacteria that our product candidates do not target that are more

meaningful drivers of the underlying disease.

In addition, our product candidates require the use of effective delivery vehicles to reach

the target organ or tissue, and there can be no assurance that our intended delivery systems will allow our product candidates to reach

the desired locations in a patient.

Safety must first be established through preclinical testing and early clinical trials, before efficacy

can be evaluated and established and thereby lead to FDA or other regulatory agencies marketing approval.

Our clinical trials may produce

undesirable side effects or negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional

clinical and/or preclinical testing or to abandon programs.

Ongoing geopolitical instability have adversely affected

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General economic, political, demographic and business

conditions worldwide, including geopolitical uncertainty and instability, such as the Israel- Hamas War and the Russia-Ukraine conflict,

might adversely affect our business, through indirect disruption to our supply chain, harming our ability to raise funds at terms acceptable

to us among other affects.

We may further experience additional disruptions that could severely impact our business, preclinical studies

and clinical trials, including:

delays or difficulties in enrolling patients in our clinical trials;

delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

interruptions or delays to our sourced discovery and clinical activities.

conditions worldwide, including geopolitical uncertainty and instability, such as the Israel’s war with Hamas and Hezbollah and

the Russia-Ukraine conflict, might adversely affect our business, through indirect disruption to our supply chain, harming our ability

to raise funds at terms acceptable to us among other affects.

We may further experience additional disruptions that could severely impact

our business, preclinical studies and clinical trials, including:

delays or difficulties in enrolling patients in our

clinical trials;

delays or difficulties in clinical site initiation,

including difficulties in recruiting clinical site investigators and clinical site staff;

interruption of, or delays in receiving, supplies of

our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages

and disruptions in delivery systems;

interruptions or delays to our sourced discovery and

clinical activities.

Changes in trade policy, including the imposition of tariffs,

may adversely affect our business, results of operations and financial condition.

and various foreign governments have

established certain trade and tariff requirements.

From time to time, the U.S.

government has indicated a willingness to revise or renegotiate

tariffs on certain goods imported into the U.S.

Since we rely on certain components from certain countries in the European Union, such

steps, if adopted, could adversely impact our business, increase our costs, and make our products less competitive.

On February 1, 2025, President Trump announced

a 10% additional tariff on imports from China and has expressed the possibility of imposing tariffs on imports from the European Union

In addition, on February 13, 2025, President Trump announced a plan to establish reciprocal tariffs with nations that impose

tariffs on U.S.

products, and directed relevant segments of the U.S.

government to assess harm of non-reciprocal trade arrangements and

to generate a report of that assessment within 180 days.

Reciprocal tariffs may be imposed prior to completion of the report.

have been statements by the Trump administration regarding a 25% tariff on pharmaceutical products.

For the year ending December 31,

2025, we estimate the impact of tariffs currently imposed on our imports from China will not be material.

We are unable to estimate the

impacts of any tariffs that have not yet been imposed by the U.S.

If we are not able to obtain, or if there are delays in obtaining,

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or any product candidates we may seek to develop in the future will ever obtain regulatory approval.

The process of obtaining regulatory approvals for

therapeutic indications, both in the United States and in other countries, is expensive, may take many years if additional clinical trials

are required, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates

Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or

regulations, or changes in regulatory review for each submitted IND, or equivalent application types, may cause delays in the approval

or rejection of an application.

The FDA and equivalent foreign regulatory authorities have substantial discretion in the approval process

and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical,

clinical or other studies.

Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons,

including the following:

the FDA or equivalent foreign regulatory authorities may disagree with the design, including study population, dose level, dose regimen, and bioanalytical assay methods, or implementation of our clinical trials;

we may be unable to demonstrate to the satisfaction of the FDA or equivalent foreign regulatory authorities that a drug candidate is safe and effective for its proposed indication or a related companion diagnostic is suitable to identify appropriate patient populations;

the results of clinical trials may not meet the level of statistical significance required by the FDA or equivalent foreign regulatory authorities for approval, such as was the case with our acne product candidate;

we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

the FDA or equivalent foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a marketing application or other submission or to obtain regulatory approval in the United States or elsewhere;

the FDA or equivalent foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

the approval policies or regulations of the FDA or equivalent foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

The process of obtaining regulatory approvals

for therapeutic indications, both in the United States and in other countries, is expensive, may take many years if additional clinical

trials are required, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product

candidates involved.

Changes in marketing approval policies during the development period, changes in or the enactment of additional

statutes or regulations, or changes in regulatory review for each submitted IND, or equivalent application types, may cause delays in

the approval or rejection of an application.

The FDA and equivalent foreign regulatory authorities have substantial discretion in the

approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional

preclinical, clinical or other studies.

There is uncertainty around new budget and staffing cuts imposed by the Trump administration

on the FDA, which may affect the timely development, approval and commercialization of new drugs.

Also, the Trump administration may

change or overhaul existing drug regulations, which would lead to additional time and money to comply with.

Furthermore, the Trump

administration’s tariffs could raise the cost of the clinical operations or affect the supply chains.

Our product candidates could

be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

the FDA or equivalent foreign regulatory authorities

may disagree with the design, including study population, dose level, dose regimen, and bioanalytical assay methods, or implementation

of our clinical trials;

we may be unable to demonstrate to the satisfaction

of the FDA or equivalent foreign regulatory authorities that a drug candidate is safe and effective for its proposed indication or

a related companion diagnostic is suitable to identify appropriate patient populations;

the results of clinical trials may not meet the level

of statistical significance required by the FDA or equivalent foreign regulatory authorities for approval, such as was the case with

our acne product candidate;

we may be unable to demonstrate that a product candidate’s

clinical and other benefits outweigh its safety risks;

the FDA or equivalent foreign regulatory authorities

may disagree with our interpretation of data from preclinical studies or clinical trials;

the data collected from clinical trials of our product

candidates may not be sufficient to support the submission of a marketing application or other submission or to obtain regulatory

approval in the United States or elsewhere;

the FDA or equivalent foreign regulatory authorities

may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and

commercial supplies;

the approval policies or regulations of the FDA or

equivalent foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Of the large number of drugs in development, only

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regulatory authorities may approve any of our product candidates for fewer or more limited therapeutic indications than our requests,

may include limitations for use or contraindications that limit the suitable patient population, may not approve the price we intend to

charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product

candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product

may include limitations for use or contraindications that limit the suitable patient population, may not approve the price we intend

to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve

a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

If we experience delays in obtaining approval or

if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our future

ability to generate revenues will be materially impaired.

If we experience delays in obtaining approval

or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our

future ability to generate revenues will be materially impaired.

We have never generated any revenue from product sales and may

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Our ability to generate meaningful revenue and

achieve profitability depends on our ability, and the ability of any third party with which we may partner, to successfully complete the

development of, and meet regulatory requirements, including (but not limited to) obtaining any necessary regulatory approvals, to commercialize

our product candidates.

We do not currently meet regulatory requirements or have the required approvals to market our product candidates

and may never meet or receive them.

We do not anticipate generating revenue from product sales for the foreseeable future, if ever.

any of our product candidates fail in clinical trials or if any of our product candidates do not meet regulatory requirements, including

gaining regulatory approval when needed, or if any of our product candidates, if marketed, fail to achieve market acceptance, we may never

become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

achieve profitability depends on our ability, and the ability of any third party with which we may partner, to successfully complete

the development of, and meet regulatory requirements, including (but not limited to) obtaining any necessary regulatory approvals, to

commercialize our product candidates.

We do not currently meet regulatory requirements or have the required approvals to market our product

candidates and may never meet or receive them.

We do not anticipate generating revenue from product sales for the foreseeable future,

If any of our product candidates fail in clinical trials or if any of our product candidates do not meet regulatory requirements,

including gaining regulatory approval when needed, or if any of our product candidates, if marketed, fail to achieve market acceptance,

we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent

Our ability to generate future revenue from product sales depends heavily on our success in:

completing research and preclinical and clinical development of our product candidates;

seeking and obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;

completing research and preclinical and clinical development

of our product candidates;

seeking and obtaining regulatory and marketing approvals

for product candidates for which we complete clinical trials;

meeting regulatory requirements for marketing the products;

developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;

launching and commercializing product candidates for which we obtain regulatory and marketing approval or are otherwise permitted to market, either by establishing a sales force, marketing and distribution infrastructure or by collaborating with a partner;

developing a sustainable, scalable, reproducible and

transferable manufacturing process for our product candidates;

launching and commercializing product candidates for

which we obtain regulatory and marketing approval or are otherwise permitted to market, either by establishing a sales force, marketing

and distribution infrastructure or by collaborating with a partner;

obtaining market acceptance of any approved products;

addressing any competing technological and market developments;

implementing additional internal systems and infrastructure, as needed;

implementing additional internal systems and infrastructure,

identifying and validating new product candidates;

negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;

maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;

negotiating favorable terms in any collaboration, licensing

or other arrangements into which we may enter;

maintaining, protecting and expanding our portfolio

of intellectual property rights, including patents, trade secrets and know-how;

attracting, hiring and retaining qualified personnel.

Even if one or more of the product candidates that

we develop is approved for commercial sale or otherwise permitted for marketing, we anticipate incurring significant costs associated

Even if one or more of the product candidates

that we develop is approved for commercial sale or otherwise permitted for marketing, we anticipate incurring significant costs associated

with commercializing any approved product.

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conditions related to the presence of certain bacteria.

Our success is largely dependent on a broad degree of market acceptance, and in

the case of drug products, physician adoption and use, which are necessary for commercial success.

Our success is largely dependent on a broad degree of market acceptance, and

in the case of drug products, physician adoption and use, which are necessary for commercial success.

Even if we obtain FDA or foreign regulatory approvals

for our drug product candidates, the commercial success of our product candidates will depend on consumer acceptance and adoption of products

that we commercialize.

Adverse events in preclinical studies and clinical trials of our product candidates or in clinical trials of others

developing similar products and the resulting publicity could result in a decrease in demand for any product that we may develop.

for our drug product candidates, the commercial success of our product candidates will depend on consumer acceptance and adoption of

products that we commercialize.

Adverse events in preclinical studies and clinical trials of our product candidates or in clinical trials

of others developing similar products and the resulting publicity could result in a decrease in demand for any product that we may develop.

In addition, the commercial success of our drug

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we have designed to meet specific characteristics.

We and our contract manufacturers produce a cocktail of multiple phage and it may be

difficult or time-consuming to achieve high titers, or levels, of phage sufficient for our preclinical and clinical testing.

In some cases,

it may require multiple product runs in order for us to obtain the amounts necessary for its clinical testing.

This may result in delays

in our clinical trial timelines, and it may increase production costs and associated expenses.

Also, it may be difficult to reproduce

the manufacturing process to the extent that more significant quantities are required as our product candidates advance through the clinical

development process.

We and our contract manufacturers produce a cocktail of multiple phage and it may

be difficult or time-consuming to achieve high titers, or levels, of phage sufficient for our preclinical and clinical testing.

cases, it may require multiple product runs in order for us to obtain the amounts necessary for its clinical testing.

This may result

in delays in our clinical trial timelines, and it may increase production costs and associated expenses.

Also, it may be difficult to

reproduce the manufacturing process to the extent that more significant quantities are required as our product candidates advance through

the clinical development process.

Results from preclinical studies of our product candidates may

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effective for their intended use.

Success in preclinical testing and early-stage clinical trials does not ensure that later clinical trials

will be successful.

Our initial results from preclinical testing also may not be confirmed by later analysis or subsequent larger clinical

A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after

obtaining promising results in earlier clinical trials, and most product candidates that commence clinical trials are never approved for

commercial sale.

Success in preclinical testing and early-stage clinical trials does not ensure that later clinical

trials will be successful.

Our initial results from preclinical testing also may not be confirmed by later analysis or subsequent larger

clinical trials.

A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials,

even after obtaining promising results in earlier clinical trials, and most product candidates that commence clinical trials are never

approved for commercial sale.

If we encounter difficulties enrolling patients in our clinical

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the eligibility criteria defined in the protocol;

the perceived benefit of the product candidate under study;

the size of the patient population required for analysis of the clinical trial’s therapeutic endpoints;

our ability to recruit clinical trial investigators and sites with the appropriate competencies and experience;

the perceived benefit of the product candidate under

the size of the patient population required for analysis

of the clinical trial’s therapeutic endpoints;

our ability to recruit clinical trial investigators

and sites with the appropriate competencies and experience;

our ability to obtain and maintain patient consents;

competition for patients from clinical trials for other treatments.

competition for patients from clinical trials for other

We have experienced and may continue to experience

difficulties in enrolling patients in our clinical trials, which could increase the costs or affect the timing or outcome of these clinical

This is particularly true with respect to diseases with relatively small patient populations.

In addition, potential patients

for our trials may not be adequately diagnosed or identified with the diseases that we are targeting or may not meet the entry criteria

for our studies.

difficulties in enrolling patients in our clinical trials, including recently with respect to enrollment in our DFO phase 2 study, which

could increase the costs or affect the timing or outcome of these clinical trials.

This is particularly true with respect to diseases

with relatively small patient populations.

In addition, potential patients for our trials may not be adequately diagnosed or identified

with the diseases that we are targeting or may not meet the entry criteria for our studies.

We may not be able to initiate or continue clinical

trials if we are unable to locate a sufficient number of eligible patients to participate in the clinical trials required by the FDA or

equivalent foreign regulatory agencies.

trials if we are unable to locate a sufficient number of eligible patients to participate in the clinical trials required by the FDA

or equivalent foreign regulatory agencies.

In addition, the process of finding and diagnosing patients may prove costly.

Our inability to

enroll a sufficient number of patients for any of our clinical trials would result in significant delays or may require us to abandon

Our inability

to enroll a sufficient number of patients for any of our clinical trials would result in significant delays or may require us to abandon

one or more clinical trials.

Delays in our clinical trials could result in us not achieving

anticipated developmental milestones when expected, increased costs and delays in our ability to obtain regulatory approval for and commercialization

of our product candidates.

Delays in our clinical trials could result in us

not meeting anticipated clinical milestones and could materially impact our product development costs and delay regulatory approval of

our product candidates.

Planned clinical trials may not be commenced or completed on schedule, or at all.

Clinical trials can be delayed for a variety of

reasons, including:

delays in the development of manufacturing capabilities for our product candidates to enable their consistent production at clinical trial scale;

failures in our internal manufacturing operations that result in our inability to consistently and timely produce bacteriophage in sufficient quantities to support our clinical trials;

the availability of financial resources to commence and complete our planned clinical trials;

delays in reaching a consensus with clinical investigators on study design;

delays in reaching a consensus with regulatory agencies on trial design or in obtaining regulatory approval to commence a trial;

in our clinical trials could result in us not achieving anticipated developmental milestones when expected, increased costs and delays

in our ability to obtain regulatory approval for and commercialization of our product candidates.

in our clinical trials could result in us not meeting anticipated clinical milestones and could materially impact our product development

costs and delay regulatory approval of our product candidates.

Planned clinical trials may not be commenced or completed on schedule,

trials can be delayed for a variety of reasons, including:

delays in the development of

manufacturing capabilities for our product candidates to enable their consistent production at clinical trial scale;

failures in our internal manufacturing operations that

result in our inability to consistently and timely produce bacteriophage in sufficient quantities to support our clinical trials;

the availability of financial resources to commence

and complete our planned clinical trials;

delays in reaching a consensus with clinical investigators

on study design;

delays in reaching a consensus with regulatory agencies

on trial design or in obtaining regulatory approval to commence a trial;

delays in obtaining clinical materials;

slower than expected patient recruitment for participation in clinical trials;

regulatory constraints or injunctions (for example, from supervisory authorities in case of noncompliance with cybersecurity and data privacy laws);

failure by clinical trial sites, other third parties or us to adhere to clinical trial agreements and/or the trial protocol;

delays in reaching agreement on acceptable clinical trial agreement terms with prospective sites or obtaining IRB or independent ethics committee approval;

adverse safety events experienced during our clinical trials.

If we do not successfully commence or complete

our clinical trials on schedule, the price of our securities may decline.

Significant preclinical or clinical trial delays could shorten

any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products

to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business

and results of operations.

Our current or future product candidates may cause adverse effects

that could halt their clinical development, prevent their approval or marketing, limit their commercial potential or result in significant

negative consequences.

Adverse effects could occur and cause us or regulatory

authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of marketing

approval by the FDA or equivalent foreign regulatory agencies.

Results of our trials could reveal a high and unacceptable severity and

prevalence of side effects or unexpected characteristics.

If adverse effects arise in the development of

our product candidates, we, the FDA or equivalent foreign regulatory agencies, the IRBs or independent ethics committees at the institutions

in which our studies are conducted, or the Data Safety Monitoring Board could suspend or terminate our clinical trials or the FDA or equivalent

foreign regulatory agencies could deny approval of our product candidates for any or all targeted indications.

We intend to continue to evaluate our product candidates

for safety and tolerability in the form of Phase 1 clinical trials.

While our current and future product candidates will undergo safety

testing to the extent possible and, where applicable, under such conditions discussed with regulatory authorities, not all adverse effects

of drugs can be predicted or anticipated.

Unforeseen adverse effects could arise either during clinical development or, if such adverse

effects are more rare, after our products have been approved by regulatory authorities and the approved product has been marketed, resulting

in the exposure of additional patients.

For example, while we screen our phage in attempts to minimize safety issues, there can be no

assurance that we will eliminate the risk of the appearance of virulence genes, antibiotic resistance genes, lysogenic genes, integrase

genes, or other toxic genes in our phage, or of adverse reactions to our phage in a patient’s immune system.

So far, we have not

demonstrated, and we cannot predict, if ongoing or future clinical trials will demonstrate that any of our product candidates are safe

Moreover, clinical trials of our product candidates are conducted in carefully defined sets of patients who have agreed to

enter into clinical trials.

Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product

candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable adverse effects.

Ultimately, some or all of our product candidates

may prove to be unsafe for human use.

Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears

to suffer, adverse health effects as a result of participating in our clinical trials.

Any of these events could prevent us from achieving

or maintaining market acceptance of our product candidates and could substantially increase commercialization costs.

We have not completed composition development of our product

The development of our product candidates requires

that we isolate, select, optimize and combine a number of phage that target the desired bacteria for that product candidate.

The selection

of phage for any of our product candidates is based on a variety of factors, including, without limitation, the ability of the selected

phage, in combination, to successfully kill the targeted bacteria, the degree of cross-reactivity of the individual phage with the same

part of the bacterial targets, the ability of the combined phage to satisfy regulatory requirements, our ability to manufacture sufficient

quantities of the phage, intellectual property rights of third parties, and other factors.

While we have selected an initial formulation

of BX004, there can be no assurance that this initial formulation will be the final formulations of this product candidate for commercialization

If we are unable to complete formulation development of our product candidates in the time frame that we have anticipated,

then our product development timelines, and the regulatory approval of our product candidates, could be delayed.

slower than expected patient recruitment for participation

in clinical trials;

regulatory constraints or injunctions (for example,

from supervisory authorities in case of noncompliance with cybersecurity and data privacy laws);

failure by clinical trial sites, other third parties

or us to adhere to clinical trial agreements and/or the trial protocol;

delays in reaching agreement on acceptable clinical

trial agreement terms with prospective sites or obtaining IRB or independent ethics committee approval;

adverse safety events experienced during our clinical

we do not successfully commence or complete our clinical trials on schedule, the price of our securities may decline.

Significant preclinical

or clinical trial delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates

or allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our

product candidates and harming our business and results of operations.

current or future product candidates may cause adverse effects that could halt their clinical development, prevent their approval or

marketing, limit their commercial potential or result in significant negative consequences.

effects could occur and cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive

label or the delay or denial of marketing approval by the FDA or equivalent foreign regulatory agencies.

Results of our trials could

reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

adverse effects arise in the development of our product candidates, we, the FDA or equivalent foreign regulatory agencies, the IRBs or

independent ethics committees at the institutions in which our studies are conducted, or the Data Safety Monitoring Board could suspend

or terminate our clinical trials or the FDA or equivalent foreign regulatory agencies could deny approval of our product candidates for

any or all targeted indications.

intend to continue to evaluate our product candidates for safety and tolerability in the form of Phase 1 clinical trials.

While our current

and future product candidates will undergo safety testing to the extent possible and, where applicable, under such conditions discussed

with regulatory authorities, not all adverse effects of drugs can be predicted or anticipated.

Unforeseen adverse effects could arise

either during clinical development or, if such adverse effects are more rare, after our products have been approved by regulatory authorities

and the approved product has been marketed, resulting in the exposure of additional patients.

For example, while we screen our phage

in attempts to minimize safety issues, there can be no assurance that we will eliminate the risk of the appearance of virulence genes,

antibiotic resistance genes, lysogenic genes, integrase genes, or other toxic genes in our phage, or of adverse reactions to our phage

in a patient’s immune system.

So far, we have not demonstrated, and we cannot predict, if ongoing or future clinical trials will

demonstrate that any of our product candidates are safe in humans.

Moreover, clinical trials of our product candidates are conducted

in carefully defined sets of patients who have agreed to enter into clinical trials.

Consequently, it is possible that our clinical trials

may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively

fail to identify undesirable adverse effects.

some or all of our product candidates may prove to be unsafe for human use.

Moreover, we could be subject to significant liability if

any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in our clinical trials.

of these events could prevent us from achieving or maintaining market acceptance of our product candidates and could substantially increase

commercialization costs.

have not completed composition development of our product candidates.

development of our product candidates requires that we isolate, select, optimize and combine a number of phage that target the desired

bacteria for that product candidate.

The selection of phage for any of our product candidates is based on a variety of factors, including,

without limitation, the ability of the selected phage, in combination, to successfully kill the targeted bacteria, the degree of cross-reactivity

of the individual phage with the same part of the bacterial targets, the ability of the combined phage to satisfy regulatory requirements,

our ability to manufacture sufficient quantities of the phage, intellectual property rights of third parties, and other factors.

we have selected an initial formulation of BX004, there can be no assurance that this initial formulation will be the final formulations

of this product candidate for commercialization if approved.

If we are unable to complete formulation development of our product candidates

in the time frame that we have anticipated, then our product development timelines, and the regulatory approval of our product candidates,

could be delayed.

must continue to develop manufacturing processes for our product candidates, and any delay in doing so, or our inability to do so, would

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Any delay or inability in establishing or expanding our manufacturing capacity could diminish our ability to develop our product candidates.

the third quarter of 2019, we established our own manufacturing facility at our headquarters in Ness Ziona, Israel and we have executed

cGMP manufacturing for our first in human clinical study.

In February 2021, APT consolidated its GMP manufacturing, testing and development

in its Gaithersburg facility.

In March 2021, we moved into a new manufacturing facility at our headquarters in Ness Ziona, Israel.

new facility undergoes ongoing internal inspections to verify proper manufacturing for Phase I and II clinical studies in accordance

with cGMP requirements.

In the event these facilities do not comply with cGMP standards for the manufacture of our product candidates,

we may need to fund additional modifications to our manufacturing process, conduct additional validation studies or find alternative

manufacturing facilities, any of which would result in significant cost to us as well as a delay of up to several years in obtaining

approval for such product candidate.

In 2019, we established our own manufacturing facility

at our headquarters in Ness Ziona, Israel and we have executed cGMP manufacturing for our first in human clinical study.

In March 2021,

we moved into a new manufacturing facility at our headquarters in Ness Ziona, Israel.

During 2024, the use of the manufacturing facility

was put on hold as part of the Company strategic decision and clinical trial material was transferred to an outsourced company.

the option to return our own facility to full GMP activity if needed and subject to sufficient funding.

In that case, we may need to fund

additional modifications to our manufacturing process and conduct additional validation studies.

As a backup we believe that we can find

alternative manufacturing facilities.

Each of the options above might result in significant cost to us as well as a delay of up to several

years in obtaining approval for such product candidate.

we submit marketing applications for any of our product candidates manufactured at this facility, this manufacturing facility will be

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may forego or delay pursuit of opportunities with other product candidates or for other indications that may prove to have greater commercial

For example, we spent significant time and resources developing BX001, which we discontinued, and our BX005 product candidates

and CRC development efforts, which we have paused indefinitely.

For example, we spent significant time and resources developing BX005, which we discontinued.

resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

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which it would have been more advantageous for us to retain sole development and commercialization rights to the product candidate.

intend to continue to rely on our BOLT proprietary product platform to develop our phage therapies.

Our competitive position could be

materially harmed if our competitors develop similar platforms and develop rival product candidates.

BOLT platform enables us to rapidly develop, manufacture and formulate phage therapy candidates targeting particular pathogenic bacteria

and incorporates our experience over the past six years with process refinement and implementation of technological advancements.

a given indication, the platform will typically allow for the completion of a clinical proof of concept study in patients, meaning Phase

2 results, within approximately 12-18 months from project initiation;

however in certain indications the length of clinical proof of

concept may be longer depending on the indication, identity of target bacteria, recruitment rate, cohort size and other factors, and

we may not achieve clinical proof of concept on that timeline, or at all.

We are initially aiming to complete a clinical proof of concept

study in patients within approximately 12-18 months from project initiation in our CF program.

We have limited experience with our BOLT

platform and may not achieve the benefits we anticipate.

To the extent we utilize our resources to further develop our BOLT platform,

we may become more dependent on its success.

is a substantial risk of product liability claims in our business.

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Regardless of merit or eventual outcome, product liability claims may result in:

delay or failure to complete

our clinical trials;

withdrawal of clinical trial

participants;

decreased demand for our product

delay or failure to complete our clinical trials;

withdrawal of clinical trial participants;

decreased demand for our product candidates;

injury to our reputation;

litigation costs;

substantial monetary awards

diversion of management or

other resources from key aspects of our operations.

substantial monetary awards against us;

diversion of management or other resources from key

aspects of our operations.

we succeed in marketing products, product liability claims could result in an FDA or equivalent foreign regulatory agency investigation

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and research patients, as well as proposed and future sales, marketing and education programs.

limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.

limited operating history compared to the long time it takes to develop phage based products may make it difficult to evaluate the success

of our business to date and to assess our future viability.

inception in 2015, BiomX Ltd.

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and providing general and administrative support for these operations.

We have not yet demonstrated our ability to successfully complete

any clinical study or other pivotal clinical trials, obtain regulatory approvals, manufacture a commercial-scale product, or arrange

for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.

Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating

Such development efforts take very long periods of time before

they can be proved successful.

We have not yet demonstrated our ability to successfully complete any clinical study or other pivotal

clinical trials, obtain regulatory approvals, manufacture a commercial-scale product, or arrange for a third-party to do so on our behalf,

or conduct sales and marketing activities necessary for successful product commercialization.

Consequently, any predictions made about

our future success or viability may not be as accurate as they could be if we had a longer operating history.

addition, as an early-stage company, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown

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Future growth would impose significant added responsibilities on members of management,

identifying, recruiting, compensating,

integrating, maintaining and motivating additional employees;

managing our internal research

and development efforts effectively, including identification of clinical candidates, scaling our manufacturing process and navigating

the clinical and FDA review process for our product candidates;

improving our operational,

financial and management controls, reporting systems and procedures.

identifying, recruiting, compensating, integrating,

maintaining and motivating additional employees;

managing our internal research and development efforts

effectively, including identification of clinical candidates, scaling our manufacturing process and navigating the clinical and FDA

review process for our product candidates;

improving our operational, financial and management

controls, reporting systems and procedures.

future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively

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may not achieve our research, development and commercialization goals.

Related to Government Regulation

Related to Government Regulation and Government

product candidates are subject to significant regulatory approval requirements, which could delay, prevent or limit our ability to market

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leads to price reductions in countries that traditionally granted high prices.

at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain

or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized

in a timely manner or at all, which could negatively impact our business.

at the FDA and other government agencies and entities, such as the U.S.

Department of Defense, caused by funding shortages global

health concerns or other causes could hinder their ability to hire, retain or deploy key leadership and other personnel, or

otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which

could negatively impact our business.

ability of the FDA to review and or approve new products can be affected by a variety of factors, including government budget and funding

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FDA have fluctuated in recent years as a result.

In addition, government funding of other government agencies that fund research and

development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other

regulatory authorities may also slow the time necessary for new drugs and biologics to be reviewed and/or approved by necessary regulatory

authorities, which would adversely affect our business.

For example, over the last several years, the U.S.

government has shut down several

times and certain regulatory authorities, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Any material reductions in the ability of FDA to perform these and other functions

may delay the development and approval of our product candidates.

Recent actions by the Trump administration have caused concern in the

industry that this may occur.

For example, beginning on February 13, 2025, the Department of Health and Human Services began firing a

large number of its probationary employees, a category that includes new federal employees and employees recently promoted or transferred

to new positions or agencies.

Reports indicate that 5,000 out of 80,000 employees have been terminated.

Although we cannot be certain

at this early stage, these terminations and others, if they withstand legal challenges, may significantly delay and impede our interactions

Similar results may stem from the recent confirmed resignations of some senior FDA employees with responsibility for regulation

of drugs and biologics, as well as possible future layoffs and resignations.

There are also reports that the Trump administration intends

to request Congress to reduce FDA funding in upcoming budgets.

Such funding cuts may also delay the development and approval of our products.

addition, government funding of other government agencies that fund research and development activities is subject to the political

process, which is inherently fluid and unpredictable.

For instance, we have funded our research and development from grants,

including grants from MTEC, a consortium working in partnership with the U.S.

Department of Defense.

In connection therewith, in

2019, APT entered into the Research Agreement, with the USAMRAA, and the USAMRDC, to advance personalized phage therapy from niche

to broad use and have received awards under this agreement.

Cost cutting of grants and other disruptions at the Department of

Defense, the FDA and other regulatory authorities may also lengthen the time necessary for new drugs and biologics to be developed,

reviewed and/or approved by necessary regulatory authorities, which would adversely affect our business, or require us to obtain alternative funding and other resources,

if available.

are subject to certain U.S.

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viable products or may not provide us with any competitive advantages or may be challenged by third parties;

others may design around our

patent claims to produce competitive products that fall outside the scope of our patents;

we may not develop additional

patentable proprietary technology related to our product candidates;

we are dependent upon the diligence

of our appointed agents in national jurisdictions, acting for and on our behalf, which control the prosecution of pending domestic

and foreign patent applications and maintain granted domestic and foreign patents.

others may design around our patent claims to produce

competitive products that fall outside the scope of our patents;

we may not develop additional patentable proprietary

technology related to our product candidates;

we are dependent upon the diligence of our appointed

agents in national jurisdictions, acting for and on our behalf, which control the prosecution of pending domestic and foreign patent

applications and maintain granted domestic and foreign patents.

issued patent does not guarantee us the right to practice the patented technology or commercialize the patented product.

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may arise between us and our licensors regarding intellectual property subject to a license agreement, including:

the scope of rights granted

under the license agreement and other interpretation-related issues;

whether, and the extent to

which, our products, services, technology and processes infringe on the intellectual property of the licensor that is not subject

to the license agreement;

our right to sublicense patent

and other rights to third parties under collaborative development relationships;

our diligence obligations under

the license agreement and what activities satisfy those diligence obligations;

the inventorship and ownership

of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators;

the priority of invention of

patented technology.

the scope of rights granted under the license agreement

and other interpretation-related issues;

whether, and the extent to which, our products, services,

technology and processes infringe on the intellectual property of the licensor that is not subject to the license agreement;

our right to sublicense patent and other rights to

third parties under collaborative development relationships;

our diligence obligations under the license agreement

and what activities satisfy those diligence obligations;

the inventorship and ownership of inventions and know-how

resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators;

the priority of invention of patented technology.

we do not prevail in such disputes, we may lose any or all of our rights under such license agreements.

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of risks, including the following:

third parties have, and future

third-party collaborators may have, significant discretion in determining the efforts and resources that they will apply;

current and future third parties

may not perform their obligations as expected;

current and future third parties

may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue

or renew development or commercialization programs based on clinical trial results, changes in the third parties’ strategic

focus or available funding, or external factors, such as a strategic transaction that may divert resources or create competing priorities;

third parties may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

current and future third parties could independently develop, or develop with third parties, products that compete directly or indirectly with our products and product candidates if the third parties believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

product candidates discovered in collaboration with us may be viewed by our current or future third parties as competitive with their own product candidates or products, which may cause such third parties to cease to devote resources to the commercialization of our product candidates;

current and future third parties may fail to comply with applicable regulatory requirements regarding the development, manufacture, distribution or marketing of a product candidate or product;

current and future third parties with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;

disagreements with current or future third parties, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or terminations of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

current and future third parties may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

current and future third parties may infringe the intellectual property rights of others, which may expose us to litigation and potential liability;

current and future third parties may infringe regulatory frameworks (such as but not limited to cybersecurity and/or privacy frameworks), which may expose us to litigation and potential liability or require or lead us to terminate relationships with them;

if a current or future third party is involved in a business combination, the collaborator might deemphasize or terminate the development or commercialization of any product candidate licensed to it by us;

current and future relationships may be terminated by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

If our relationships do not result in the successful

discovery, development and commercialization of products or if one of our third-party collaborators terminates its agreement with us,

we may not receive any future research funding or milestone or royalty payments under the collaboration.

If we do not receive the funding

we expect under these agreements, our development of our technology and product candidates could be delayed, and we may need additional

resources to develop product candidates and our technology.

Additionally, if any of our current or future third-party collaborators terminates

its agreement with us, we may find it more difficult to attract new collaborators, and our reputation in the business and financial communities

could be adversely affected.

Relationships are complex and time-consuming to

negotiate and document.

In addition, there have been a significant number of recent business combinations among large pharmaceutical companies

that have resulted in a reduced number of potential future collaborators.

We face significant competition in seeking appropriate collaborators.

Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of a collaborator’s

resources and expertise, the terms and conditions of a proposed collaboration and a proposed collaborator’s evaluation of a number

We may not be successful in maintaining or establishing collaborations,

which could adversely affect our ability to develop and, if required regulatory approvals are obtained, commercialize our product candidates.

In the future, in order to advance our clinical

development, or in connection with any potential out-licensing of product candidates or technologies, we may seek to enter into collaboration

In addition, we may consider entering into collaboration arrangements with medical technology, pharmaceutical or biotechnology

companies and/or seek to establish strategic relationships with marketing partners for the development, sale, marketing and/or distribution

of our product candidates within or outside of the United States.

If we are unable to reach agreements with potential collaborators, then

we may fail to meet our business objectives for the affected product candidates or programs.

Collaboration arrangements are complex and

time-consuming to negotiate, document and implement, and we may not be successful in our efforts, if any, to establish and implement collaborations

or other alternative arrangements.

The terms of any collaboration or other arrangements that we establish may not be favorable to us,

and the success of any such collaboration will depend heavily on the efforts and activities of our collaborators.

Moreover, our collaboration

agreement could be terminated or not renewed by a third party at a time that is costly or damaging to us.

Any failure to engage successful

collaborators could cause delays in our product development and/or commercialization efforts, which could harm our financial condition

and operational results.

Risks Related to Our Operations in Israel

Our headquarters, research and development and other significant

operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability

in Israel, including the recent war with Hamas and other terrorist organizations from the Gaza Strip.

Our executive offices and research and development

facilities are located in Israel.

In addition, the majority of our key employees and all of our officers are residents of Israel.

political, geopolitical, economic and military conditions in Israel may directly affect our business.

Since the establishment of the State

of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring Arab countries, the Hamas (an Islamist

terrorist militia and political group that controls the Gaza strip), the Hezbollah (an Islamist terrorist militia and political group

based in Lebanon) and other terrorist organizations active in the region.

These conflicts have involved missile strikes, hostile infiltrations

and terrorism against civilian targets in various parts of Israel, which have negatively affected business conditions in Israel.

Any hostilities

involving Israel or the interruption or curtailment of trade between Israel and its trading partners could negatively affect business

conditions in Israel in general and our business in particular, and adversely affect our product development, operations and results of

In October 2023, Hamas terrorists infiltrated Israel’s

southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.

Hamas also launched extensive

rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas

within the State of Israel.

These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers.

Following the

attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced

in parallel to their continued rocket and terror attacks.

In addition, since the commencement of these events, there have been continued

hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and southern border (with the Houthi

movement in Yemen, as described below).

It is possible that hostilities with Hezbollah in Lebanon will escalate, and that other terrorist

organizations, including Palestinian military organizations in the West Bank as well as other hostile countries, such as Iran, will join

the hostilities.

Such clashes may escalate in the future into a greater regional conflict.

In connection with the Israeli security cabinet’s declaration

of war against Hamas and possible hostilities with other organizations, several hundred thousand Israeli military reservists were drafted

to perform immediate military service, including 9 employees, none of whom are management or key employees, who were called up for reserve

service, of which 4 have since returned to work full time and their pre-war military reserve duty.

So long as the war continues, our personnel

may be called up for reserve service, whether for an extended periods or periodically for short-term periods.

Military service call ups

that result in absences of personnel for an extended period of time may materially and adversely affect our business, prospects, financial

condition and results of operations.

Since the war broke out on October 7, 2023,

our operations have not been adversely affected by this situation, and we have not experienced disruptions to our business operations.

third parties have, and future third-party collaborators

may have, significant discretion in determining the efforts and resources that they will apply;

current and future third parties may not perform their

obligations as expected;

current and future third parties may not pursue development

and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development

or commercialization programs based on clinical trial results, changes in the third parties’ strategic focus or available funding,

or external factors, such as a strategic transaction that may divert resources or create competing priorities;

third parties may delay clinical trials, provide insufficient

funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials

or require a new formulation of a product candidate for clinical testing;

current and future third parties could independently

develop, or develop with third parties, products that compete directly or indirectly with our products and product candidates if

the third parties believe that the competitive products are more likely to be successfully developed or can be commercialized under

terms that are more economically attractive than ours;

product candidates discovered in collaboration with

us may be viewed by our current or future third parties as competitive with their own product candidates or products, which may cause

such third parties to cease to devote resources to the commercialization of our product candidates;

current and future third parties may fail to comply

with applicable regulatory requirements regarding the development, manufacture, distribution or marketing of a product candidate

current and future third parties with marketing and

distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources

to the marketing and distribution of such product or products;

disagreements with current or future third parties,

including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays

or terminations of the research, development or commercialization of product candidates, might lead to additional responsibilities

for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and

current and future third parties may not properly maintain

or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could

jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

current and future third parties may infringe the intellectual

property rights of others, which may expose us to litigation and potential liability;

current and future third parties may infringe regulatory

frameworks (such as but not limited to cybersecurity and/or privacy frameworks), which may expose us to litigation and potential

liability or require or lead us to terminate relationships with them;

if a current or future third party is involved in a

business combination, the collaborator might deemphasize or terminate the development or commercialization of any product candidate

licensed to it by us;

current and future relationships may be terminated

by the collaborator, and, if terminated, we could be required to raise additional capital to pursue further development or commercialization

of the applicable product candidates.

our relationships do not result in the successful discovery, development and commercialization of products or if one of our third-party

collaborators terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under

the collaboration.

If we do not receive the funding we expect under these agreements, our development of our technology and product candidates

could be delayed, and we may need additional resources to develop product candidates and our technology.

Additionally, if any of our

current or future third-party collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators,

and our reputation in the business and financial communities could be adversely affected.

Relationships

are complex and time-consuming to negotiate and document.

In addition, there have been a significant number of recent business combinations

among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We face significant competition

in seeking appropriate collaborators.

Our ability to reach a definitive agreement for a collaboration will depend, among other things,

upon our assessment of a collaborator’s resources and expertise, the terms and conditions of a proposed collaboration and a proposed

collaborator’s evaluation of a number of factors.

may not be successful in maintaining or establishing collaborations, which could adversely affect our ability to develop and, if required

regulatory approvals are obtained, commercialize our product candidates.

the future, in order to advance our clinical development, or in connection with any potential out-licensing of product candidates or

technologies, we may seek to enter into collaboration agreements.

In addition, we may consider entering into collaboration arrangements

with medical technology, pharmaceutical or biotechnology companies and/or seek to establish strategic relationships with marketing partners

for the development, sale, marketing and/or distribution of our product candidates within or outside of the United States.

unable to reach agreements with potential collaborators, then we may fail to meet our business objectives for the affected product candidates

Collaboration arrangements are complex and time-consuming to negotiate, document and implement, and we may not be successful

in our efforts, if any, to establish and implement collaborations or other alternative arrangements.

The terms of any collaboration or

other arrangements that we establish may not be favorable to us, and the success of any such collaboration will depend heavily on the

efforts and activities of our collaborators.

Moreover, our collaboration agreement could be terminated or not renewed by a third party

at a time that is costly or damaging to us.

Any failure to engage successful collaborators could cause delays in our product development

and/or commercialization efforts, which could harm our financial condition and operational results.

Related to Our Operations in Israel

headquarters, research and development and other significant operations are located in Israel, and, therefore, our results may be adversely

affected by political, economic and military instability in Israel, including the recent war with Hamas and other terrorist organizations

from the Gaza Strip.

executive offices and research and development facilities are located in Israel.

In addition, the majority of our key employees and all

of our officers are residents of Israel.

Accordingly, political, geopolitical, economic and military conditions in Israel may directly

affect our business.

Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel

and its neighboring Arab countries, the Hamas (an Islamist terrorist militia and political group that controls the Gaza strip), the Hezbollah

(an Islamist terrorist militia and political group based in Lebanon) and other terrorist organizations active in the region.

These conflicts

have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively

affected business conditions in Israel.

Any hostilities involving Israel or the interruption or curtailment of trade between Israel and

its trading partners could negatively affect business conditions in Israel in general and our business in particular, and adversely affect

our product development, operations and results of operations.

Following the October 2023 attacks by Hamas terrorists

in Israel’s southern border, Israel declared a war against Hamas and since then, Israel has been involved in military conflicts

with Hamas, Hezbollah, a terrorist organization based in Lebanon, and Iran, both directly and through proxies such as the Houthi movement

in Yemen, armed groups in Iraq and other terrorist organizations.

Additionally, following the fall of the Assad regime in Syria, Israel

has conducted limited military operations targeting certain Syrian military assets, Iranian military assets and infrastructure linked

to Hezbollah and other Iran-supported groups.

Although a ceasefire agreement has been reached with Lebanon (with respect to Hezbollah)

there is no assurance that this agreement will be upheld.

Military activity and hostilities continue to exist at varying levels of intensity,

and the situation remains volatile, with the potential for escalation into a broader regional conflict involving additional terrorist

organizations and possibly other countries.

Furthermore, the fall of the Assad regime in Syria may create additional geopolitical instability

in the region.

connection with the ongoing war against Hamas and Hezbollah and possible hostilities with other organizations, several hundred thousand

Israeli military reservists were drafted to perform immediate military service, including 5 employees, none of whom are management or

key employees, who were called up for reserve service, of which 5 have since returned to work full time and their pre-war military reserve

So long as the war continues, our personnel may be called up for reserve service, whether for extended periods or periodically

for short-term periods.

Military service call ups that result in absences of personnel for an extended period of time may materially

and adversely affect our business, prospects, financial condition and results of operations.

the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced

disruptions to our business operations.

As such, our product and business development activities remain on track.

However, the intensity and duration of Israel’s current

war against Hamas is difficult to predict at this stage, as are such war’s economic implications on our business and operations

and on Israel’s economy in general.

If the war extends for a long period of time or expands to other fronts, such as Lebanon, Syria

and the West Bank, our operations may be adversely affected.

Any armed conflicts, terrorist activities or political

instability in the region could adversely affect business conditions, could harm our results of operations and the market price of our

Common Stock, and could make it more difficult for us to raise capital.

Our commercial insurance does not cover losses

that may occur as a result of an event associated with the security situation in the Middle East.

Although the Israeli government has

in the past covered the reinstatement value of certain damages that were caused by terrorist attacks or acts of war, we cannot assure

you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred.

However, the intensity

and duration of Israel’s current war is difficult to predict at this stage, as are such war’s economic implications on our

business and operations and on Israel’s economy in general.

If the war extends for a long period of time or expands to other fronts,

such as Syria and the West Bank, our operations may be adversely affected.

armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our

results of operations and the market price of our Common Stock, and could make it more difficult for us to raise capital.

commercial insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle

Although the Israeli government has in the past covered the reinstatement value of certain damages that were caused by terrorist

attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to

compensate us fully for damages incurred.

Any losses or damages incurred by us could have a material adverse effect on our business.

Finally, political conditions within Israel may

affect our operations.

Israel has held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government

pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest.

To date, these initiatives

have been substantially put on hold.

Actual or perceived political instability in Israel or any negative changes in the political environment,

may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of

operations and growth prospects.

Our operations may be disrupted as a result of the obligation

of management or key personnel to perform military service.

As of the date hereof, we currently have 99 full-time

employees, of which 64 are located in Israel, including 5 members of our senior management.

Certain of our employees and consultants in

Israel, including members of our senior management, may be obligated to perform military reserve duty generally until they reach the age

of 40 (or older, for officers or other citizens who hold certain positions in the Israeli armed forces reserves) and, in the event of

a military conflict, may be called to active duty.

In response to increases in terrorist activity, there have been periods of significant

call-ups of military reservists.

It is possible that there will be similar large-scale military reserve duty call-ups in

Our operations could be disrupted by the absence of a significant number of our officers, directors, employees and consultants.

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 negatively impact our business operations.

political conditions within Israel may affect our operations.

Prior to October 7, 2023, the Israeli government pursued extensive changes

to Israel’s judicial system, which sparked extensive political debate and unrest.

Since October 7, 2023, these initiatives have

been put on hold;

however, the Israeli government has recently renewed its efforts to effect such changes.

Actual or perceived political

instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the

Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

operations may be disrupted as a result of the obligation of management or key personnel to perform military service.

of the date hereof, we currently have 50 full-time employees, of which 41 are located in Israel, including 3 members of our senior

Certain of our employees and consultants in Israel, including members of our senior management, may be obligated to perform

military reserve duty generally until they reach the age of 40 (or older, for officers or other citizens who hold certain positions in

the Israeli armed forces reserves) and, in the event of a military conflict, may be called to active duty.

In response to increases in

terrorist activity, there have been periods of significant call-ups of military reservists.

It is possible that there will be similar

large-scale military reserve duty call-ups in the future.

Our operations could be disrupted by the absence of a significant

number of our officers, directors, employees and consultants.

Such disruption could materially adversely affect our business and operations.

The Israeli government grants we have received for research and

development expenditures restrict our ability to manufacture products and transfer technology outside of Israel and require us to satisfy

specified conditions.

If we fail to satisfy these conditions, we may be required to refund grants previously received, together with interest

and penalties.

Our research and development efforts have been

financed, in part, through the grants that we have received from the Israeli Innovation Authority, or the IIA.

We, therefore, must comply

with the requirements of Israel’s Law for the Encouragement of Research and Development in Industries, or the Research Law.

the years ended December 31, 2023 and 2022, we recorded grants totaling $1.0 million and $1.1 million, from the IIA, respectively.

grants represented 7.3% and 6.1% of our gross research and development expenditures for the years ended December 31, 2023 and 2022, respectively.

Under the Research Law, we are required to manufacture

the major portion of each of our products developed using these grants in the State of Israel or otherwise ask for special approvals.

We may not receive the required approvals for any proposed transfer of manufacturing activities.

Even if we receive approval to manufacture

products developed with government grants outside of Israel, the royalty rate may be increased, and we may be required to pay up to 300%

of the grant amounts, plus interest, depending on the manufacturing volume that is performed outside of Israel.

This restriction may impair

our ability to outsource manufacturing or engage in our own manufacturing operations for those products or technology.

Additionally, under the Research Law, we are prohibited

from transferring, including by way of license, the IIA-financed technology and related intellectual property rights and know-how outside

of the State of Israel, except under limited circumstances and only with the approval of the IIA Research Committee.

We may not receive

the required approvals for any proposed transfer, and, even if received, we may be required to pay the IIA a portion, to be set by the

IIA, in its discretion and taking into account the circumstances, upon its approval of such transaction, of the consideration or milestone

and royalty payments that we receive upon any sale or out-licensing of such technology to a non-Israeli entity, up to 600% of the grant

amounts plus interest.

These restrictions may impair our ability to sell

our technology assets or to perform or outsource manufacturing outside of Israel or otherwise transfer our know-how outside of Israel

and may require us to obtain the approval of the IIA for certain actions and transactions and pay additional royalties and other amounts

In addition, any change of control and any change of ownership of our Common Stock that would make a non-Israeli citizen or

resident an “interested party,” as defined in the Research Law, requires prior written notice to the IIA, and our failure

to comply with this requirement could, under certain circumstances, result in criminal liability.

These restrictions will continue to apply even

after we have repaid the full amount of royalties on the grants.

We have received, and may continue to receive, Israeli governmental

grants to assist in the funding of our research and development activities.

If we lose our funding from these research and development

grants, we may encounter difficulties in the funding of future research and development projects and implementing technological improvements,

which would harm our operating results.

Israeli government grants we have received for research and development expenditures restrict our ability to manufacture products and

transfer technology outside of Israel and require us to satisfy specified conditions.

If we fail to satisfy these conditions, we may

be required to refund grants previously received, together with interest and penalties.

research and development efforts have been financed, in part, through the grants that we have received from the Israeli Innovation Authority,

We therefore must comply with the requirements of Israel’s Law for the Encouragement of Research and Development in

Industries, or the Research Law.

For the year ended December 31, 2024 no grants were recorded.

For the year ended December 31,2023, we

recorded grants totaling $1.0 million from the IIA which represented 7.3% of our gross research and development.

the Research Law, we are required to manufacture the major portion of each of our products developed using these grants in the State

of Israel or otherwise ask for special approvals.

We may not receive the required approvals for any proposed transfer of manufacturing

Even if we receive approval to manufacture products developed with government grants outside of Israel, the royalty rate

may be increased, and we may be required to pay up to 300% of the grant amounts, plus interest, depending on the manufacturing volume

that is performed outside of Israel.

This restriction may impair our ability to outsource manufacturing or engage in our own manufacturing

operations for those products or technology.

Additionally,

under the Research Law, we are prohibited from transferring, including by way of license, the IIA-financed technology and related intellectual

property rights and know-how outside of the State of Israel, except under limited circumstances and only with the approval of the IIA

Research Committee.

We may not receive the required approvals for any proposed transfer, and, even if received, we may be required to

pay the IIA a portion, to be set by the IIA, in its discretion and taking into account the circumstances, upon its approval of such transaction,

of the consideration or milestone and royalty payments that we receive upon any sale or out-licensing of such technology to a non-Israeli

entity, up to 600% of the grant amounts plus interest.

restrictions may impair our ability to sell our technology assets or to perform or outsource manufacturing outside of Israel or otherwise

transfer our know-how outside of Israel and may require us to obtain the approval of the IIA for certain actions and transactions and

pay additional royalties and other amounts to the IIA.

In addition, any change of control and any change of ownership of our Common Stock

that would make a non-Israeli citizen or resident an “interested party,” as defined in the Research Law, requires prior written

notice to the IIA, and our failure to comply with this requirement could, under certain circumstances, result in criminal liability.

restrictions will continue to apply even after we have repaid the full amount of royalties on the grants.

have received, and may continue to receive, Israeli governmental grants to assist in the funding of our research and development activities.

If we lose our funding from these research and development grants, we may encounter difficulties in the funding of future research and

development projects and implementing technological improvements, which would harm our operating results.

Through December 31, 2024, we had received an aggregate

of $8.0 million in the form of grants from the IIA.

was formed as an incubator company as part of the FutuRx incubator, and,

until 2017, the majority of our funding was from IIA grants and funding by the incubator, which is supported by the IIA.

to apply for and receive IIA grants after we left the incubator.

The requirements and restrictions for such grants are found in the Research

Under the Research Law, royalties of 3% to 3.5% on the revenue derived from sales of products or services developed in whole or in

part using these IIA grants are payable to the Israeli government.

We developed both of our platform technologies, at least in part, with

funds from these grants, and, accordingly, we would be obligated to pay these royalties on sales of any of our product candidates that

achieve regulatory approval.

As long as the manufacturing of our product candidates takes place in Israel and no technology funded with

IIA grants is sold or out licensed to a non-Israeli entity, the maximum aggregate royalties paid generally would not exceed 100% of the

grants made to us, plus annual interest equal to the 12-month Secured Overnight Financing Rate, or SOFR, applicable to dollar deposits,

as published on the first trading day of each calendar year.

As of December 31, 2023, the balance of the principal and interest in respect

of our commitments for future payments to the IIA totaled approximately $7.9 million.

As part of funding our current and planned product

development activities, we may submit follow-up grant applications for additional grants.

These grants have funded some of our personnel,

development activities with subcontractors, and other research and development costs and expenses.

However, if these awards are not funded

in their entirety or if additional grants are not awarded in the future, due to, for example, IIA budget constraints or governmental policy

decisions, our ability to fund future research and development and implement technological improvements would be impaired, which would

negatively impact our ability to develop our product candidates.

Exchange rate fluctuations between the U.S.

Dollar, the New Israeli

Shekel, the Euro and other foreign currencies, may negatively affect our future expenses.

Our proceeds from sales of our securities are generally

received in U.S.

Our headquarters are located in Israel, where the majority of our general and administrative expenses and research

and development costs are incurred in the New Israeli Shekel, or NIS.

Future expenses may be incurred in foreign currencies such as the

Euro or British Pound.

As a result, our financial results may be affected by fluctuations in the exchange rates of currencies in the countries.

For example, during 2020, we witnessed a strengthening of the average exchange rate of the NIS against the U.S.

Dollar, which increased

originated within the FutuRx IIA supported incubator, with primary funding

through 2017 coming from IIA.

We continued to apply for and receive IIA grants after we left the incubator.

The requirements and restrictions

for such grants are found in the Research Law.

Under the Research Law, royalties of 3% to 3.5% on the revenue derived from sales of products

or services developed in whole or in part using these IIA grants are payable to the Israeli government.

We developed both of our platform

technologies, at least in part, with funds from these grants, and, accordingly, we would be obligated to pay these royalties on sales

of any of our product candidates that achieve regulatory approval.

As long as the manufacturing of our product candidates takes place

in Israel and no technology funded with IIA grants is sold or out licensed to a non-Israeli entity, the maximum aggregate royalties paid

generally would not exceed 100% of the grants made to us, plus annual interest equal to the 12-month Secured Overnight Financing Rate,

or SOFR, applicable to dollar deposits, as published on the first trading day of each calendar year.

As of December 31, 2024, the balance

of the principal and interest in respect of our commitments for future payments to the IIA totaled approximately $8.3 million.

of funding our current and planned product development activities, we may submit follow-up grant applications for additional grants.

grants have funded some of our personnel, development activities with subcontractors, and other research and development costs and expenses.

However, if these awards are not funded in their entirety or if additional grants are not awarded in the future, due to, for example,

IIA budget constraints or governmental policy decisions, our ability to fund future research and development and implement technological

improvements would be impaired, which would negatively impact our ability to develop our product candidates.

rate fluctuations between the U.S.

Dollar, the New Israeli Shekel, the Euro and other foreign currencies, may negatively affect our future

proceeds from sales of our securities are generally received in U.S.

Our headquarters are located in Israel, where the majority

of our general and administrative expenses and research and development costs are incurred in the New Israeli Shekel, or NIS.

expenses may be incurred in foreign currencies such as the Euro or British Pound.

As a result, our financial results may be affected

by fluctuations in the exchange rates of currencies in the countries.

For example, during 2024, we witnessed a weakening of the average

exchange rate of the NIS against the U.S.

Dollar, which decreased the U.S.

Dollar value of Israeli expenses.

If the NIS strengthens against the U.S.

If the NIS weakens against

Dollar, as it did in 2024 and 2023, the U.S.

value of our Israeli expenses, mainly personnel and facility-related, will increase.

We use foreign exchange contracts (mainly option

and forward contracts) to hedge balance sheet items from currency exposure.

However, these foreign exchange contracts are not designated

as hedging instruments for accounting purposes and they may not be effective.

Although exposure to currency fluctuations to date has not

had a material adverse effect on our business, there can be no assurance that fluctuations in the future will not have a material adverse

effect on our operating results and financial condition.

Under applicable employment laws, we may not be able to enforce

covenants not to compete.

We generally enter into noncompetition agreements

with our employees.

These agreements prohibit our employees, if they cease working for us, from competing directly with us or working

for our competitors or clients for a limited period.

We may be unable to enforce these agreements under the laws of the jurisdictions

in which our employees work, and it may be difficult for us to restrict our competitors from benefitting from the expertise our former

employees or consultants developed while working for us.

For example, Israeli labor courts have required employers seeking to enforce

noncompete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a

limited number of material interests of the employer that have been recognized by the courts, such as the protection of a company’s

trade secrets or other intellectual property.

The tax benefits that are available to us if and when we generate

taxable income require us to meet various conditions and may be prevented or reduced in the future, which could increase our costs and

If and when we generate taxable income, we would

be eligible for certain tax benefits provided to “Technologic Preferred Enterprise” and/or “Preferred Enterprise”

as defined under the Encouragement of Capital Investment Law -1959, the Law, and its regulations, as amended and, accordingly, could be

subject to a reduced corporate tax rate on its income that will meet the provisions of the Law (ranging between 7.5%-16%).

To the extent

that we are not eligible to obtain such statuses, our Israeli taxable income would be subject to regular Israeli corporate tax rates.

Dollar value of our Israeli expenses, mainly personnel and facility-related, will

We use foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure.

However, these foreign exchange contracts are not designated as hedging instruments for accounting purposes and they may not be effective.

Although exposure to currency fluctuations to date has not had a material adverse effect on our business, there can be no assurance that

fluctuations in the future will not have a material adverse effect on our operating results and financial condition.

applicable employment laws, we may not be able to enforce covenants not to compete.

generally enter into noncompetition agreements with our employees.

These agreements prohibit our employees, if they cease working for

us, from competing directly with us or working for our competitors or clients for a limited period.

We may be unable to enforce these

agreements under the laws of the jurisdictions in which our employees work, and it may be difficult for us to restrict our competitors

from benefitting from the expertise our former employees or consultants developed while working for us.

For example, Israeli labor courts

have required employers seeking to enforce noncompete undertakings of a former employee to demonstrate that the competitive activities

of the former employee will harm one of a limited number of material interests of the employer that have been recognized by the courts,

such as the protection of a company’s trade secrets or other intellectual property.

tax benefits that are available to us if and when we generate taxable income require us to meet various conditions and may be prevented

or reduced in the future, which could increase our costs and taxes.

and when we generate taxable income, we would be eligible for certain tax benefits provided to “Technologic Preferred Enterprise”

and/or “Preferred Enterprise” as defined under the Encouragement of Capital Investment Law -1959, the Law, and its regulations,

as amended and, accordingly, could be subject to a reduced corporate tax rate on its income that will meet the provisions of the Law

(ranging between 7.5%-16%).

To the extent that we are not eligible to obtain such statuses, our Israeli taxable income would be subject

to regular Israeli corporate tax rates.

The standard corporate tax rate for Israeli companies is 23%.

The benefits available to us in accordance to the Law and its regulations

are subject to the fulfillment of conditions stipulated in the Law and the regulations.

Further, in the future, these tax benefits may

be reduced or discontinued.

It may be difficult to enforce a U.S.

judgment against us or

our officers and directors in Israel or the United States or to assert U.S.

securities laws claims in Israel or serve process on our officers

and directors.

Not all of our directors or officers are residents

of the United States, and most of their and our assets are located outside the United States.

The benefits available to us in

accordance to the Law and its regulations are subject to the fulfillment of conditions stipulated in the Law and the regulations.

in the future, these tax benefits may be reduced or discontinued.

may be difficult to enforce a U.S.

judgment against us or our officers and directors in Israel or the United States or to assert U.S.

securities laws claims in Israel or serve process on our officers and directors.

all of our directors or officers are residents of the United States, and most of their and our assets are located outside the United

Service of process upon us or our non-U.S.

resident directors and officers may be difficult to obtain within the United States.

Israeli courts may refuse to hear a claim based on

a violation of U.S.

Israeli courts may refuse to hear a claim based on a violation of U.S.

securities laws against us or our non-U.S.

officers and directors, because Israel may not be the most appropriate

forum to bring such a claim.

In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law, and not

officers and directors,

because Israel may not be the most appropriate forum to bring such a claim.

In addition, 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.

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.

Additionally, Israeli courts might not enforce judgments obtained in the United

States against us or our non-U.S.

directors and executive officers, which may make it difficult to collect on judgments rendered against

us or our non-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.

Additionally, Israeli

courts might not enforce judgments obtained in the United States against us or our non-U.S.

directors and executive officers, which may

make it difficult to collect on judgments rendered against us or our non-U.S.

officers and directors.

Moreover, an Israeli court will not enforce a non-Israeli

judgment if it was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional

cases), if its enforcement is likely to prejudice the sovereignty or security of the State of Israel, if it was obtained by fraud or in

the absence of due process, if it is at variance with another valid judgment that was given in the same matter between the same parties,

or if a suit in the same matter between the same parties was pending before a court or tribunal in Israel at the time the foreign action

Risks Related to Manufacturing and Supply

We rely on third parties to manufacture our clinical supply of

product candidates and we intend to rely on third parties to produce and process our products, if approved.

We currently rely on outside vendors to supply

raw materials and other important components, such as lab equipment.

We have not yet caused any product candidates to be manufactured

or processed on a commercial scale and may not be able to do so for any of our product candidates.

We will make changes as it works to

optimize the manufacturing process for our product candidates, and we cannot be sure that even minor changes in the process will result

in therapies that are safe and effective.

The facilities used to manufacture our product

candidates must be approved by the FDA or equivalent foreign regulatory agencies pursuant to inspections that will be conducted after

we submit a marketing application to the FDA or equivalent foreign regulatory agency.

Additionally, any facilities used for the manufacture

of product candidates commercialized for non-therapeutic uses will be subject to inspection by the FDA and foreign regulatory agencies.

We do not currently control all aspects of the manufacturing process of, and are currently largely dependent on, our contract manufacturing

partners for compliance with regulatory requirements, known as cGMP requirements, for manufacture of our product candidates.

our manufacturing facility becomes operational, we will be responsible for compliance with cGMP requirements.

If we or our contract manufacturers

cannot successfully manufacture in conformance with our specifications and the strict regulatory requirements of the FDA or other regulatory

authorities, we and they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities with respect

to the manufacture of our product candidates.

In addition, we have no control over the ability of our contract manufacturers to maintain

adequate quality control, quality assurance and qualified personnel.

If the FDA or an equivalent foreign regulatory agency does not approve

these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find

alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market

our product candidates, if approved.

We have limited experience manufacturing our product

candidates for purposes of clinical trials for therapeutic indications or for non-therapeutic clinical studies or trials.

We opened our

own manufacturing facility at our headquarters in Ness Ziona, Israel in 2019.

We cannot assure you that we can manufacture our product

candidates in compliance with regulations at a cost or in quantities necessary to make them commercially viable.

Our product candidates rely on the availability of specialty

raw materials, which may not be available to us on acceptable terms or at all.

Our product candidates require certain specialty

raw materials, some of which we obtain from small companies with limited resources and experience to support a commercial product.

third-party suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like an FDA inspection or medical

crisis, such as widespread contamination.

We do not currently have contracts in place with all of the suppliers that we may need at any

point in time and, if needed, may not be able to contract with them on acceptable terms or at all.

Accordingly, we may experience delays

in receiving key raw materials to support clinical or commercial manufacturing.

Risks Related to Our Common Stock

A significant number of shares of our Common Stock are subject

to issuance upon exercise of outstanding warrants and options or conversion of our Convertible Preferred Stock, which upon such exercise

or conversion, as applicable, may result in dilution to our security holders.

As of December 31, 2023, we had an aggregate of

25,363,688 warrants outstanding to purchase an aggregate of up to 20,926,189 shares of Common Stock with a weighted average exercise price

of $2.60, certain of which, or the Unit Warrants are included in our outstanding units, each consisting of one share of Common Stock and

one warrant exercisable for one-half of one share of Common Stock, or the Units, certain of which were issued in private placements, or

Private Warrants, certain of which, or the Pre-funded Warrants, were issued in the February 2023 PIPE, and certain of which, or the Public

Warrants, were previously traded on NYSE American under the symbol “PHGE.WS,” and are currently quoted on OTC Pink under the

symbol “PHGEW”.

Unit Warrants, Private Warrants, Pre-funded Warrants and Public Warrants, collectively, or the Outstanding

Warrants, in each case subject to adjustment.

To the extent such Outstanding Warrants are exercised, additional shares of our Common Stock

will be issued, which will result in dilution to the then existing holders of Common Stock and increase the number of shares eligible

for resale in the public market.

Sales of substantial numbers of such shares in the public market could adversely affect the market price

of our Common Stock.

In addition, as of December 31, 2023, we had outstanding

vested and unvested options to purchase 5,280,711 shares of our Common Stock.

To the extent any of these options are exercised, additional

shares of Common Stock will be issued that will generally be eligible for resale in the public market (subject to limitations under Rule

144 under the Securities Act with respect to shares held by our affiliates), which will result in dilution to our security holders.

Furthermore, (i) in connection with the Acquisition,

in addition to issuance of Common Stock, we issued (a) an aggregate of 40,470 shares of Convertible Preferred Stock, which, in the event

our stockholders approve the conversion of the Convertible Preferred Stock at the Stockholder Meeting, will be convertible into an aggregate

of up to 40,470,000 shares of our Common Stock, and (b) warrants, or Merger Warrants, which, in the event our stockholders approve the

exercise of the Merger Warrants at the Stockholder Meeting, will be exercisable for an aggregate of 2,416,497 shares of Common Stock,

and (ii) in connection with the March 2024 PIPE, we issued (x) an aggregate of 216,417 shares of Convertible Preferred Stock, which, in

the event our stockholders approve the conversion of the Convertible Preferred Stock at the Stockholder Meeting, will be convertible into

an aggregate of up to 216,417,000 shares of Common Stock, and (y) Private Placement Warrants, which, in the event our stockholders approve

the exercise of the Private Placement Warrants at the Stockholder Meeting, will be exercisable for an aggregate of 108,208,500 shares

of our Common Stock.

Additionally, as partial compensation to the placement agents for the March 2024 PIPE, we issued warrants, or Placement

Agent Warrants, and collectively with the Merger Warrants and the Private Placement Warrants, the Warrants, which, in the event our stockholders

approve the conversion of the Placement Agent Warrants at the Stockholder Meeting, will be exercisable for up to an aggregate of 9,523,809

shares of Common Stock.

To the extent any of the Convertible Preferred Stock is converted or any of the Warrants are exercised, additional

shares of Common Stock will be issued that, subject to applicable securities laws, will generally be eligible for resale in the public

market (subject to limitations under Rule 144 under the Securities Act with respect to shares held by our affiliates).

Sales of substantial

numbers of such shares in the public market could adversely affect the market price of our Common Stock.

We plan to grant additional options, subject to

stockholder approval at the Stockholder Meeting and may issue additional warrants and shares of preferred stock in the future.

the issuance of additional shares of our Common Stock upon exercise of such securities, as applicable, will result in dilution to the

then existing holders of Common Stock and could also have an adverse effect on the market price of our Common Stock.

We have never paid dividends on our Common Stock, and we do not

anticipate paying any cash dividends on our Common Stock in the foreseeable future.

We have never declared or paid cash dividends on

our Common Stock.

We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future.

We currently intend to

retain all available funds and any future earnings to fund the development and growth of our business.

As a result, capital appreciation,

if any, of our Common Stock will be our stockholders’ sole source of gain for the foreseeable future.

Our Public Warrants have been delisted, and we may be unable

to maintain the listing of our securities in the future.

Our Common Stock and Units trade on NYSE American.

Our Public Warrants previously traded on NYSE American but were delisted in June 2023 and since then have been quoted on OTC Pink.

a result of the delisting of our Public Warrants, the holders thereof have experienced a limited availability of market quotations and

reduced liquidity with respect to their Public Warrants.

If our Common Stock or Units are subsequently delisted, we could face significant

material adverse consequences, including:

a limited availability of market quotations for our securities;

an Israeli court will not enforce a non-Israeli judgment if it was given in a state whose laws do not provide for the enforcement of

judgments of Israeli courts (subject to exceptional cases), if its enforcement is likely to prejudice the sovereignty or security of

the State of Israel, if it was obtained by fraud or in the absence of due process, if it is at variance with another valid judgment that

was given in the same matter between the same parties, or if a suit in the same matter between the same parties was pending before a

court or tribunal in Israel at the time the foreign action was brought.

Related to Manufacturing and Supply

rely on third parties to manufacture our clinical supply of product candidates and we intend to rely on third parties to produce and

process our products, if approved.

currently rely on outside vendors to supply raw materials and other important components, such as lab equipment.

Additionally, our clinical

trial material is being manufactured by an outsourced contract manufacturing operation as our current GMP facility was put on hold.

have not yet caused any product candidates to be manufactured or processed on a commercial scale and may not be able to do so for any

of our product candidates.

We will make changes as it works to optimize the manufacturing process for our product candidates, and we

cannot be sure that even minor changes in the process will result in therapies that are safe and effective.

facilities used to manufacture our product candidates must be approved by the FDA or equivalent foreign regulatory agencies pursuant

to inspections that will be conducted after we submit a marketing application to the FDA or equivalent foreign regulatory agency.

Additionally,

any facilities used for the manufacture of product candidates commercialized for non-therapeutic uses will be subject to inspection by

the FDA and foreign regulatory agencies.

We do not currently control all aspects of the manufacturing process of, and are currently largely

dependent on, our contract manufacturing partners for compliance with regulatory requirements, known as cGMP requirements, for manufacture

of our product candidates.

If and when our manufacturing facility becomes operational, we will be responsible for compliance with cGMP

requirements.

If we or our contract manufacturers cannot successfully manufacture in conformance with our specifications and the strict

regulatory requirements of the FDA or other regulatory authorities, we and they will not be able to secure and/or maintain regulatory

approval for their manufacturing facilities with respect to the manufacture of our product candidates.

In addition, we have no control

over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

FDA or an equivalent foreign regulatory agency does not approve these facilities for the manufacture of our product candidates or if

it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact

our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

have limited experience manufacturing our product candidates for purposes of clinical trials for therapeutic indications or for non-therapeutic

clinical studies or trials.

We opened our own manufacturing facility at our headquarters in Ness Ziona, Israel in 2019, but it has currently

been put on hold.

We cannot assure you that we can manufacture our product candidates in compliance with regulations at a cost or in

quantities necessary to make them commercially viable.

product candidates rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

product candidates require certain specialty raw materials, some of which we obtain from small companies with limited resources and experience

to support a commercial product.

These third-party suppliers may be ill-equipped to support our needs, especially in non-routine circumstances

like an FDA inspection or medical crisis, such as widespread contamination.

We do not currently have contracts in place with all of the

suppliers that we may need at any point in time and, if needed, may not be able to contract with them on acceptable terms or at all.

Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.

Related to Our Common Stock

significant number of shares of our Common Stock are subject to issuance upon exercise of outstanding warrants and options or conversion

of our Convertible Preferred Stock, which upon such exercise or conversion, as applicable, may result in dilution to our security holders.

As of December 31, 2024, we had warrants outstanding

to purchase an aggregate of up to 12,296,430 shares of Common Stock with a weighted average exercise price of $4.34, or collectively,

the Outstanding Warrants, in each case subject to adjustment.

To the extent such Outstanding Warrants are exercised, additional shares

of our Common Stock will be issued, which will result in dilution to the then existing holders of Common Stock and increase the number

of shares eligible for resale in the public market.

Sales of substantial numbers of such shares in the public market could adversely

affect the market price of our Common Stock.

addition, as of December 31, 2024, we had outstanding vested and unvested options to purchase 2,002,365 shares of our Common Stock.

the extent any of these options are exercised, additional shares of Common Stock will be issued that will generally be eligible for resale

in the public market (subject to limitations under Rule 144 under the Securities Act with respect to shares held by our affiliates),

which will result in dilution to our security holders.

As of March 20, 2025, and following the February 2025 SPA (as defined

below), we had warrants outstanding to purchase an aggregate of up to 14,391,386 shares of Common Stock with a weighted average exercise

price of $2.97.

may issue additional options, warrants and shares of preferred stock in the future.

Furthermore, the issuance of additional shares of

our Common Stock upon exercise of such securities, as applicable, will result in dilution to the then existing holders of Common Stock

and could also have an adverse effect on the market price of our Common Stock.

have never paid dividends on our Common Stock, and we do not anticipate paying any cash dividends on our Common Stock in the foreseeable

have never declared or paid cash dividends on our Common Stock.

We do not anticipate paying any cash dividends on our Common Stock in

the foreseeable future.

We currently intend to retain all available funds and any future earnings to fund the development and growth

of our business.

As a result, capital appreciation, if any, of our Common Stock will be our stockholders’ sole source of gain for

the foreseeable future.

may be unable to maintain the listing of our securities in the future.

Common Stock trades on NYSE American, which imposes continued listing requirements with respect to listed shares.

If we fail to satisfy

the continued listing standards, such as, for example, the requirement that our shares not trade "for a substantial period of time

at a low price per share" or fail to meet stockholders equity requirements, among other requirements, the NYSE American may issue

a non-compliance letter or initiate delisting proceedings.

If our Common Stock is delisted, we could face significant material adverse

consequences, including:

a limited availability of market quotations for our

reduced liquidity with respect to our securities;

a determination that our shares are a “penny stock,” which will require brokers trading in our securities to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our securities;

a limited amount of news and analyst coverage for the Company;

a decreased ability to issue additional securities or obtain additional financing in the future.

The market price of our Common Stock and other securities may

be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our Common Stock.

The stock markets in general and the markets for

biotechnology stocks have experienced extreme volatility.

The market for the common stock of smaller companies such as ours is characterized

by significant price volatility when compared to the shares of larger, more established companies that trade on a national securities

exchange and have large public floats, and our share price is more volatile than the shares of such larger, more established companies

for the indefinite future.

In addition to the factors discussed in this “Risk

Factors” section, price declines in our Common Stock (and other securities) could also result from general market and economic conditions

and a variety of other factors, including:

a determination that our shares are a “penny

stock,” which will require brokers trading in our securities to adhere to more stringent rules, possibly resulting in a reduced

level of trading activity in the secondary trading market for our securities;

a limited amount of news and analyst coverage for the

a decreased ability to issue additional securities

or obtain additional financing in the future.

market price of our Common Stock and other securities may be volatile and fluctuate substantially, which could result in substantial

losses for purchasers of our Common Stock.

stock markets in general and the markets for biotechnology stocks have experienced extreme volatility.

The market for the common stock

of smaller companies such as ours is characterized by significant price volatility when compared to the shares of larger, more established

companies that trade on a national securities exchange and have large public floats, and our share price is more volatile than the shares

of such larger, more established companies for the indefinite future.

addition to the factors discussed in this “Risk Factors” section, price declines in our Common Stock (and other securities)

could also result from general market and economic conditions and a variety of other factors, including:

adverse results or delays in our clinical trials;

adverse actions taken by regulatory agencies with respect to our product candidates, clinical trials or the manufacturing processes of our product candidates;

announcements of technological innovations, patents or new products by our competitors;

regulatory developments in the United States and foreign countries;

adverse actions taken by regulatory agencies with respect

to our product candidates, clinical trials or the manufacturing processes of our product candidates;

announcements of technological innovations, patents

or new products by our competitors;

regulatory developments in the United States and foreign

any lawsuit involving us or our product candidates;

announcements concerning our competitors, or the biotechnology or pharmaceutical industries in general;

developments concerning any strategic alliances or acquisitions we may enter into;

announcements concerning our competitors, or the biotechnology

or pharmaceutical industries in general;

developments concerning any strategic alliances or

acquisitions we may enter into;

actual or anticipated variations in our operating results;

changes in recommendations by securities analysts or lack of analyst coverage;

deviations in our operating results from the estimates of analysts;

our inability, or the perception by investors that we will be unable, to continue to meet all applicable requirements for continued listing of our Common Stock on NYSE American, and the possible delisting of our Common Stock;

sales of our Common Stock by our executive officers, directors and principal stockholders or sales of substantial amounts of Common Stock;

changes in recommendations by securities analysts or

lack of analyst coverage;

deviations in our operating results from the estimates

our inability, or the perception by investors that

we will be unable, to continue to meet all applicable requirements for continued listing of our Common Stock on NYSE American, and

the possible delisting of our Common Stock;

sales of our Common Stock by our executive officers,

directors and principal stockholders or sales of substantial amounts of Common Stock;

loss of any of our key scientific or management personnel.

Additionally, market prices for securities of biotechnology

companies historically have been very volatile.

The market for these securities has from time to time experienced significant price and

volume fluctuations for reasons unrelated to the operating performance of any one company.

Furthermore, our business may be adversely

impacted by risks, or the public perception of the risks, related to a pandemic or other health crisis, such as the COVID-19 or as a result

of the Israel-Hamas War or the Russian invasion of Ukraine and the resulting world sanctions on Russia, Belarus, and related parties.

A significant outbreak of contagious diseases could result in a widespread health crisis that could adversely affect the economies and

financial markets of many countries, resulting in an economic downturn.

In the past, following periods of volatility in

the market price of a particular company’s securities, litigation has often been brought against that company.

Any such lawsuit

could consume resources and management time and attention, which could adversely affect our business.

As a “smaller reporting company” we are permitted

to provide less disclosure than larger public companies, which may make our Common Stock less attractive to investors.

We are currently a “smaller reporting company,”

as defined by Rule 12b-2 of the Exchange Act.

As a smaller reporting company, we are eligible to take advantage of certain exemptions

from various reporting requirements applicable to other public companies.

Consequently, it may be more challenging for investors to analyze

our results of operations and financial prospects which may result in less investor confidence.

Investors may find our Common Stock less

attractive as a result of our smaller reporting company status.

If some investors find our Common Stock less attractive, there may be

a less active trading market for our Common Stock and our stock price may be more volatile.

General Risk Factors

Our success depends, in part, on our ability to retain key executives

and to attract, retain and motivate qualified personnel.

We are highly dependent on Jonathan Solomon, our

chief executive officer, as well as the other principal members of our management, scientific and clinical team.

Although we have entered

into employment agreements with our executive officers, each of them may terminate their employment with us at any time.

We do not maintain

“key person” insurance for any of our executives or other employees.

The loss of the services of any of our executive officers,

other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delays

in product development and harm our business.

Additionally, our recent acquisition of APT and its integration into the Company’s

business may increase the likelihood that employees depart in the foreseeable future.

Our continued ability to attract, retain and motivate

highly qualified management, clinical and scientific personnel and our ability to develop and maintain important relationships with leading

academic institutions, clinicians and scientists is critical to our success.

Competition for qualified personnel in the biotechnology

field is intense, particularly in Israel where our headquarters are located.

We face competition for personnel from other biotechnology

and pharmaceutical companies, universities, public and private research institutions and other organizations.

We also face competition

from other more well-funded and well-established businesses, and we may also be viewed as a riskier choice from a job stability perspective

due to our relatively newer status than longer existing biotech and pharmaceutical companies.

We may not be able to attract and retain

qualified personnel on acceptable terms given the competition for such personnel.

If we are unsuccessful in our retention, motivation

and recruitment efforts, we may be unable to execute our business strategy.

Expectations relating to environmental, social and governance

(ESG) programs may impose additional costs and expose us to new risks.

There is an increasing focus from certain investors

and other key stakeholders concerning corporate responsibility, specifically related to environmental, social and governance, or ESG,

As a result, there is an increased emphasis on corporate responsibility ratings and a number of third parties provide reports

on companies in order to measure and assess corporate responsibility performance.

In addition, the ESG factors by which companies’

corporate responsibility practices are assessed may change, which could result in greater expectations of us and cause us to undertake

costly initiatives to satisfy such new criteria.

Alternatively, if we are unable to satisfy such new criteria, investors may conclude

that our policies with respect to corporate responsibility are inadequate.

We risk damage to our brand and reputation if our corporate

responsibility procedures or standards do not meet the standards set by various constituencies.

We may be required to make investments

in matters related to ESG, which could be significant and adversely impact our results of operations.

Furthermore, if our competitors’

corporate responsibility performance is perceived to be greater than ours, potential or current investors may elect to invest with our

competitors instead.

In addition, if we communicate certain initiatives and goals regarding ESG matters, we could fail, or be perceived

to fail, in our achievement of such initiatives or goals, or we could be criticized for the scope of such initiatives or goals.

fail to satisfy the expectations of investors and other key stakeholders or our initiatives are not executed as planned, our reputation

and financial results could be materially and adversely affected.

If we engage in future acquisitions or strategic partnerships,

this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject

us to other risks.

On March 15, 2024, we acquired APT.

We may evaluate

various additional acquisition opportunities and strategic partnerships, including licensing or acquiring complementary products, intellectual

property rights, technologies or businesses.

Any potential acquisition or strategic partnership may entail numerous risks, including:

Additionally,

market prices for securities of biotechnology companies historically have been very volatile.

The market for these securities has from

time to time experienced significant price and volume fluctuations for reasons unrelated to the operating performance of any one company.

Furthermore, our business may be adversely impacted by risks, or the public perception of the risks, related to a pandemic or other health

crisis, or as a result of the Israel’s war with Hamas and Hezbollah or the Russian invasion of Ukraine and the resulting world

sanctions on Russia, Belarus, and related parties.

A significant outbreak of contagious diseases could result in a widespread health

crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn.

the past, following periods of volatility in the market price of a particular company’s securities, litigation has often been brought

against that company.

Any such lawsuit could consume resources and management time and attention, which could adversely affect our business.

a “smaller reporting company” we are permitted to provide less disclosure than larger public companies, which may make our

Common Stock less attractive to investors.

are currently a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act.

As a smaller reporting company,

we are eligible to take advantage of certain exemptions from various reporting requirements applicable to other public companies.

Consequently,

it may be more challenging for investors to analyze our results of operations and financial prospects which may result in less investor

Investors may find our Common Stock less attractive as a result of our smaller reporting company status.

If some investors

find our Common Stock less attractive, there may be a less active trading market for our Common Stock and our stock price may be more

success depends, in part, on our ability to retain key executives and to attract, retain and motivate qualified personnel.

are highly dependent on Jonathan Solomon, our chief executive officer, as well as the other principal members of our management, scientific

and clinical team.

Although we have entered into employment agreements with our executive officers, each of them may terminate their

employment with us at any time.

We do not maintain “key person” insurance for any of our executives or other employees.

loss of the services of any of our executive officers, other key employees, and other scientific and medical advisors, and our inability

to find suitable replacements could result in delays in product development and harm our business.

Additionally, our recent acquisition

of APT and its integration into the Company’s business may increase the likelihood that employees depart in the foreseeable future.

continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel and our ability to develop

and maintain important relationships with leading academic institutions, clinicians and scientists is critical to our success.

for qualified personnel in the biotechnology field is intense, particularly in Israel where our headquarters are located.

We face competition

for personnel from other biotechnology and pharmaceutical companies, universities, public and private research institutions and other

organizations.

We also face competition from other more well-funded and well-established businesses, and we may also be viewed as a riskier

choice from a job stability perspective due to our relatively newer status than longer existing biotech and pharmaceutical companies.

We may not be able to attract and retain qualified personnel on acceptable terms given the competition for such personnel.

unsuccessful in our retention, motivation and recruitment efforts, we may be unable to execute our business strategy.

relating to environmental, social and governance (ESG) programs may impose additional costs and expose us to new risks.

is an increasing focus from certain investors and other key stakeholders concerning corporate responsibility, specifically related to

environmental, social and governance, or ESG, factors.

As a result, there is an increased emphasis on corporate responsibility ratings

and a number of third parties provide reports on companies in order to measure and assess corporate responsibility performance.

the ESG factors by which companies’ corporate responsibility practices are assessed may change, which could result in greater expectations

of us and cause us to undertake costly initiatives to satisfy such new criteria.

Alternatively, if we are unable to satisfy such new

criteria, investors may conclude that our policies with respect to corporate responsibility are inadequate.

We risk damage to our brand

and reputation if our corporate responsibility procedures or standards do not meet the standards set by various constituencies.

be required to make investments in matters related to ESG, which could be significant and adversely impact our results of operations.

Furthermore, if our competitors’ corporate responsibility performance is perceived to be greater than ours, potential or current

investors may elect to invest with our competitors instead.

In addition, if we communicate certain initiatives and goals regarding ESG

matters, we could fail, or be perceived to fail, in our achievement of such initiatives or goals, or we could be criticized for the scope

of such initiatives or goals.

If we fail to satisfy the expectations of investors and other key stakeholders or our initiatives are not

executed as planned, our reputation and financial results could be materially and adversely affected.

we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause

us to incur debt or assume contingent liabilities, and subject us to other risks.

March 15, 2024, we acquired APT.

We may evaluate various additional acquisition opportunities and strategic partnerships, including licensing

or acquiring complementary products, intellectual property rights, technologies or businesses.

Any potential acquisition or strategic

partnership may entail numerous risks, including:

increased operating expenses and cash requirements;

the assumption of additional indebtedness or contingent liabilities;

the assumption of additional indebtedness or contingent

the issuance of our equity securities;

assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and marketing approvals;

our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

Our business and operations would suffer

in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

Despite the implementation of security measures,

our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural

disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments

to emails, persons inside our organization, or persons with access to systems inside our organization.

The risk of a security breach or

disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists,

has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development

For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in

our clinical trial efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or

security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary

information, we could incur material legal claims and liability, and damage to our reputation, and the further development of our product

candidates could be delayed.

We also maintain compliance programs to address the potential applicability of restrictions against trading

while in possession of material, nonpublic information generally and in connection with a cyber-security breach.

However, a breakdown

in existing controls and procedures around our cyber-security environment may prevent us from detecting, reporting or responding to cyber

incidents in a timely manner and could have a material adverse effect on our financial position and value of our stock.

We incur significant costs operating as a public company.

As a public company, we incur significant costs

in connection with our directors and officers insurance, paying for service providers such as legal and accounting as well as other expenses.

We are subject to the reporting requirements of the Exchange Act, which require, among other things, that we file with the SEC annual,

quarterly and current reports with respect to our business and financial condition.

In addition, the Sarbanes-Oxley Act, as well as rules

subsequently adopted by the SEC and NYSE American to implement provisions of the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform

and Consumer Protection Act, or the Dodd-Frank Act, and the Public Company Accounting Oversight Board impose significant requirements

on public companies, including requiring the establishment and maintenance of effective disclosure and financial controls and changes

in corporate governance practices.

These expenses will likely increase in the future, particularly if we cease to be a “smaller

reporting company”, as a result of additional corporate governance and disclosure requirements under the Sarbanes-Oxley Act, the

Dodd-Frank Act, and SEC rules and regulations.

The rules and regulations applicable to public

companies result in us continuing to incur substantial legal and financial compliance costs.

These costs increase our net loss or decrease

any net income and may require us to reduce costs in other areas of our business.

assimilation of operations, intellectual property and

products of an acquired company, including difficulties associated with integrating new personnel;

the diversion of our management’s attention from

our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

retention of key employees, the loss of key personnel

and uncertainties in our ability to maintain key business relationships;

risks and uncertainties associated with the other party

to such a transaction, including the prospects of that party and their existing products or product candidates and marketing approvals;

our inability to generate revenue from acquired technology

and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and

maintenance costs.

business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to

damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or

cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside

our organization.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer

hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted

attacks and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations,

it could result in a material disruption of our product development programs.

For example, the loss of clinical trial data from completed

or ongoing or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs to recover

or reproduce the data.

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications,

or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage

to our reputation, and the further development of our product candidates could be delayed.

We also maintain compliance programs to address

the potential applicability of restrictions against trading while in possession of material, nonpublic information generally and in connection

with a cyber-security breach.

However, a breakdown in existing controls and procedures around our cyber-security environment may prevent

us from detecting, reporting or responding to cyber incidents in a timely manner and could have a material adverse effect on our financial

position and value of our stock.

incur significant costs operating as a public company.

a public company, we incur significant costs in connection with our directors and officers insurance, paying for service providers such

as legal and accounting as well as other expenses.

We are subject to the reporting requirements of the Exchange Act, which require, among

other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition.

addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and NYSE American to implement provisions of the Sarbanes-Oxley

Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, and the Public Company Accounting Oversight

Board impose significant requirements on public companies, including requiring the establishment and maintenance of effective disclosure

and financial controls and changes in corporate governance practices.

These expenses will likely increase in the future, particularly

if we cease to be a “smaller reporting company”, as a result of additional corporate governance and disclosure requirements

under the Sarbanes-Oxley Act, the Dodd-Frank Act, and SEC rules and regulations.

rules and regulations applicable to public companies result in us continuing to incur substantial legal and financial compliance costs.

These costs increase our net loss or decrease any net income and may require us to reduce costs in other areas of our business.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors