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Item 1A. Risk Factors

2023-03-29 compared with 2022-03-30 · 1137 added, 1080 removed, 1384 unchanged (62% of the section changed)

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factors, including those set forth below.

Risks Related to Our Business, Technology and

Risks Related to Our Business, Technology and Industry

We are a clinical-stage company with limited operating history

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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,

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.

● 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.

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

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increase our debt towards third parties.

As of December 31, 2021, we had cash, cash

equivalents and restricted cash of $63.1 million, and we have had recurring losses from operations and negative operating cash flows

since inception.

We will need to raise additional capital in the future to support our operations and product development

In the near term, we expect to continue to fund our operations and other development activities relating to additional

product candidates from the cash held by us, governmental and other grants and through future equity and debt financings.

agreements with respect to additional tranches of our loan with Hercules Capital, Inc., or Hercules, and an additional equity

investment by the CF Foundation, but each of these commitments is subject to us meeting future milestones, which may not occur.

connection with our efforts to raise additional capital, we filed a shelf registration statement on Form S-3, which was declared

effective by the SEC on December 11, 2020.

In addition, on December 4, 2020, we entered into an Open Market Sale

Agreement SM , or the Sale Agreement, with Jefferies LLC, or Jefferies, pursuant to which we may issue and sell shares of

our Common Stock having an aggregate offering price of up to $50,000,000 from time to time through Jefferies.

As of December 31, 2022, we had cash, cash equivalents

and restricted cash of $32.3 million, and we have had recurring losses from operations and negative operating cash flows since inception.

We will need to raise additional capital in the future to support our operations and product development activities.

In the near term,

we expect to continue to fund our operations and other development activities relating to additional product candidates from the cash

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

In February 2023, we closed the first part of

a private investment in public equity, or PIPE, financing, raising approximately $1.5 million in gross proceeds.

The second closing for

the PIPE is contingent upon approval of the issuance of the securities to be issued therein by the Company’s stockholders in accordance

with NYSE American rules, which is expected to take place in the second quarter of 2023.

If such second closing occurs, we expect to raise

an additional $6 million in gross proceeds.

In connection with our efforts to raise additional capital, we filed a shelf registration

statement on Form S-3, which was declared effective by the SEC on December 11, 2020.

In addition, on December 4, 2020, we entered into

an Open Market Sale Agreement SM , or the Sale Agreement, with Jefferies LLC, or Jefferies, pursuant to which we may issue and

sell shares of our Common Stock having an aggregate offering price of up to $50,000,000 from time to time through Jefferies.

Through March

24, 2023, we sold an aggregate of 983,184 shares of Common Stock pursuant to the Sale Agreement for aggregate gross proceeds of $5,693,968.

We may continue to sell shares under the Sale Agreement and otherwise to use our shelf registration statement to raise

additional funds from time to time, as we did in July 2021.

We may also raise funds privately, as we did in October 2021 in our

agreements with a subsidiary of Maruho Co.

Ltd., or Maruho, and in December 2021 with the CF Foundation.

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.

If we do not meet the milestones in our agreements

with Hercules or the CF Foundation and/or additional capital is not available to us when needed or on acceptable terms, we may not be able

to continue to operate our business pursuant to our business plan and may be required to delay our clinical development.

While we believe

that our existing cash and cash equivalents, together with our existing resources, will be sufficient to fund our planned operations until

at least the end of 2023, we cannot provide assurances that our estimates are accurate, that our plans will not change or that changed

circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.

We may continue to sell shares under the Sale Agreement and otherwise to use our shelf registration statement to raise additional funds

from time to time, as we did in July 2021.

We may also raise funds privately, as we did in the PIPE investment in February 2023, which

is still pending completion, as well as in other cases in 2021.

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.

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.

If the second closing of the PIPE does not occur for

any reason and/or additional capital is not available to us when needed or on acceptable terms, we may not be able to continue to operate

our business pursuant to our business plan and may be required to delay our clinical development.

While we believe that our existing cash

and cash equivalents, together with our existing resources, will be sufficient to fund our planned operations until at least the middle

of 2024, we cannot provide assurances that our estimates are accurate, that our plans will not change or that changed circumstances will

not result in the depletion of our capital resources more rapidly than we currently anticipate.

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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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.

The terms of our

term loan agreement with Hercules place restrictions on our operating and financial flexibility.

If we raise additional capital through

debt financing, the terms of any new debt could further restrict our ability to operate our business.

August 2021, we entered into a term loan agreement, or the Hercules Loan Agreement, providing for a term loan in an aggregate principal

amount of up to $30.0 million, subject to funding in three tranches and subject to certain terms and conditions.

We received the first

tranche of $15.0 million promptly after signing the agreement in August 2021.

Two additional tranches in the amounts of $10 million and

$5 million may become available to us to borrow upon the occurrence of certain milestone events.

Our obligations under the Hercules Loan

Agreement are secured by a lien on substantially all of our assets, other than intellectual property.

We also agreed not to pledge or

secure our intellectual property to others.

Hercules Loan Agreement includes affirmative and negative covenants and events of default applicable to us.

The affirmative covenants

include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports

and maintain insurance coverage.

The negative covenants include, among others, restrictions on our transferring collateral, making changes

to the nature of our business, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other

distributions, making investments, engaging in transactions with affiliates.

Events of default include, among other things and subject

to customary exceptions:

(i) insolvency, liquidation, bankruptcy or similar events;

(ii) failure to pay any debts due under the Hercules

Loan Agreement or other loan documents on a timely basis;

(iii) failure to observe certain covenants under the loan and security agreement

with Hercules;

(v) occurrence of a material adverse effect;

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.

The terms of our term loan agreement

with Hercules place restrictions on our operating and financial flexibility.

If we raise additional capital through debt financing, the

terms of any additional debt could further restrict our ability to operate our business.

In August 2021, we entered

into a term loan agreement, or the Hercules Loan Agreement, providing for a term loan in an aggregate principal amount of up to $30.0

million, subject to funding in three tranches and subject to certain terms and conditions.

We received the first tranche of $15.0 million

promptly after signing the agreement in August 2021.

The second tranche of $10.0 million did not become available to us since certain

milestones were not met.

A third additional tranche in the amount of $5 million could become available to us to borrow upon the occurrence

of certain milestone events until September 2023;

however, we do not expect such milestones to occur.

Our obligations under the Hercules

Loan Agreement are secured by a lien on substantially all of our assets, other than intellectual property.

We also agreed not to pledge

or secure our intellectual property to others.

The Hercules Loan Agreement

includes affirmative and negative covenants and events of default applicable to us.

The affirmative covenants include, among others, covenants

requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports and maintain insurance coverage.

The negative covenants include, among others, restrictions on our transferring collateral, making changes to the nature of our business,

incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments,

engaging in transactions with affiliates.

Events of default include, among other things and subject to customary exceptions:

(i) insolvency,

liquidation, bankruptcy or similar events;

(ii) failure to pay any debts due under the Hercules Loan Agreement or other loan documents

on a timely basis;

(iii) failure to observe certain covenants under the loan and security agreement with Hercules;

(v) occurrence of a

material adverse effect;

(vi) material misrepresentation by us;

(vii) occurrence of any default under

any other agreement involving material indebtedness;

(vii) occurrence of any default under any other agreement involving material

indebtedness;

and (viii) certain material money judgments.

If we default under the Hercules Loan

Agreement, Hercules may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us

to renegotiate our agreement on terms less favorable to us or to immediately cease operations.

Further, if we are liquidated, the lenders’

right to repayment would be senior to the rights of the holders of our Common Stock to receive any proceeds from the liquidation.

declaration by Hercules of an event of default could significantly harm our business and prospects and could cause the price of our Common

Stock to decline.

If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and

financial flexibility.

If we default under the Hercules Loan Agreement, Hercules may accelerate all

of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less

favorable to us or to immediately cease operations.

Further, if we are liquidated, the lenders’ right to repayment would be senior

to the rights of the holders of our Common Stock to receive any proceeds from the liquidation.

Any declaration by Hercules of an event

of default could significantly harm our business and prospects and could cause the price of our Common Stock to decline.

If we raise any

additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

We are seeking to develop product candidates using phage technology,

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approved as a drug in the United States or in the European Union.

We are developing our product candidates with

phage technology.

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

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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.

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.

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

potential advantages or disadvantages over alternative treatments;

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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In addition, general economic, political, demographic and business conditions worldwide, including

geopolitical uncertainty and instability, such as 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.

Also, due to the COVID-19

pandemic we have modified our business practices, including restricting employee travel, developing social distancing plans for our employees

and cancelling physical participation in meetings, events and conferences.

geopolitical uncertainty and instability, such as 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.

Also, due to the COVID-19 pandemic

we have modified our business practices, including restricting employee travel, developing social distancing plans for our employees and

cancelling physical participation in meetings, events and conferences.

As a result of the COVID-19 pandemic, we have experienced

and may continue to experience additional disruptions that could severely impact our business, preclinical studies and clinical trials,

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;

diversion of healthcare resources away from the conduct

of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct

of our clinical trials;

interruption of key clinical trial activities, such

as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, in the

and the government in Israel, employers and others or interruption of clinical trial subject visits and study procedures (such

as endoscopies that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

interruption or delays in the operations of the FDA

or other regulatory authorities, which may impact review and approval timelines;

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;

limitations on employee resources that would otherwise

be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees

to avoid contact with large groups of people;

interruptions or delays

to our sourced discovery and clinical activities.

● 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;

● diversion of healthcare resources

away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff

supporting the conduct of our clinical trials;

● interruption of key clinical

trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state

governments, in the U.S.

and the government in Israel, employers and others or interruption of clinical trial subject visits and study

procedures (such as endoscopies that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

● interruption or delays in the

operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

● 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;

● limitations on employee resources

that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or

the desire of employees to avoid contact with large groups of people;

interruptions or delays to our sourced discovery and clinical activities.

The pandemic and the resulting government actions

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Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers,

may have heightened exposure to COVID-19 has been impeded and may continue to remain impeded, which would adversely impact

our clinical trial operations.

may have heightened exposure to COVID-19 has been impeded and may continue to remain impeded, which would adversely impact our

clinical trial operations.

The diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns,

including the attention of physicians serving as our clinical trial investigators and hospitals serving as our clinical trial sites,

may significantly disrupt our research activities.

including the attention of physicians serving as our clinical trial investigators and hospitals serving as our clinical trial sites, may

significantly disrupt our research activities.

As a result, the expected timeline for data readouts of our clinical trials and certain

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The extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which

are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of

the pandemic, travel restrictions and social distancing in the United States Canada, Europe, Israel and other countries, business closures

are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the

pandemic, travel restrictions and social distancing in the United States Canada, Europe, Israel and other countries, business closures

or business disruptions and the effectiveness of actions taken in the United States, Canada, Europe, Israel and other countries to contain

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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

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 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 candidate.

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

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 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

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.

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;

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;

obtaining market acceptance of any approved products;

addressing any competing technological and market developments;

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;

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

● 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;

● obtaining market acceptance

of any approved products;

● addressing any competing technological

and market developments;

● implementing additional internal

systems and infrastructure, as needed;

● 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;

● 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

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.

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.

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.

Results from preclinical studies of our product candidates may

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Preclinical studies of our product candidates,

such as BX003, including studies in animal disease models in the case of BX003 and other studies, may not accurately predict the safety

of the product candidate such that further human clinical trials would be allowed to proceed.

In particular, promising preclinical testing

suggesting the potential efficacy of prototype phage products may not predict the ability of these products to address conditions in the

human clinical settings.

For example, while we have studied phage activity in vitro and in vivo , in the case of BX003, these

results may not be replicated when our phage cocktails are administered to human subjects.

Despite promising data in any preclinical studies,

our phage technology may be found not to be efficacious when studied in clinical trials.

such as BX004 and BX005, including studies in animal disease models in the case of BX003 and other studies, may not accurately predict

the safety of the product candidate such that further human clinical trials would be allowed to proceed.

In particular, promising preclinical

testing suggesting the potential efficacy of prototype phage products may not predict the ability of these products to address conditions

in the human clinical settings.

For example, while we have studied phage activity in vitro and in vivo , in the case of BX003,

these results may not be replicated when our phage cocktails are administered to human subjects.

Despite promising data in any preclinical

studies, our phage technology may be found not to be efficacious when studied in clinical trials.

To satisfy FDA or equivalent foreign regulatory

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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 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.

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.

Our product candidates are subject to significant regulatory

approval requirements, which could delay, prevent or limit our ability to market our product candidates.

research and development activities, preclinical studies, clinical trials and the anticipated manufacturing and marketing of our drug

product candidates are subject to extensive regulation by the FDA and other regulatory agencies in the United States and by comparable

authorities in Europe and elsewhere.

To satisfy FDA or equivalent foreign regulatory approval standards, we must demonstrate in adequate

and well controlled clinical trials that our drug product candidates are safe and effective for their intended use.

The regulatory approval

process is expensive and time-consuming, and the timing of receipt of regulatory approval is difficult to predict.

Given the uncertainties

around phage therapy, our product candidates could require a significantly longer time to gain regulatory approval than expected or may

never gain approval.

This is especially so for the product candidate designed to treat CRC as the phage will be genetically modified,

which adds potential complexity to the process, particularly in the European Union.

We cannot be certain that, even after expending substantial

time and financial resources, we will obtain regulatory approval for any of our product candidates.

A delay or denial of regulatory approval

could delay or prevent our ability to generate product revenue and to achieve profitability.

Our research and development activities, preclinical

studies, clinical trials and the anticipated manufacturing and marketing of our drug product candidates are subject to extensive regulation

by the FDA and other regulatory agencies in the United States and by comparable authorities in Europe and elsewhere.

To satisfy FDA or

equivalent foreign regulatory approval standards, we must demonstrate in adequate and well controlled clinical trials that our drug product

candidates are safe and effective for their intended use.

The regulatory approval process is expensive and time-consuming, and the timing

of receipt of regulatory approval is difficult to predict.

Given the uncertainties around phage therapy, our product candidates could

require a significantly longer time to gain regulatory approval than expected or may never gain approval.

This is especially so for the

product candidate designed to treat CRC as the phage will be genetically modified, which adds potential complexity to the process, particularly

in the European Union.

We cannot be certain that, even after expending substantial time and financial resources, we will obtain regulatory

approval for any of our product candidates.

A delay or denial of regulatory approval could delay or prevent our ability to generate product

revenue and to achieve profitability.

Regulatory requirements for development of our

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of phage therapy remains unclear in many countries, including the European Union.

Changes in regulatory approval policies during the

development period of any of our product candidates, changes in, or the enactment of, additional regulations or statutes, or changes

in regulatory review practices for a submitted product application may cause a delay in obtaining approval or result in the rejection

of an application for regulatory approval.

Regulatory approval, if obtained, may be made

subject to limitations on the indicated uses for which we may market a product, as well as the approved labeling for the product.

limitations could adversely affect our potential product revenue.

Regulatory approval may also be conditioned on costly post-marketing

follow-up studies.

In addition, the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping related

to the product will be subject to extensive ongoing regulatory requirements.

Furthermore, for any marketed product, our manufacturer

and our manufacturing facilities will be subject to registration and listing requirements and continual review and periodic inspections

by the FDA or other regulatory authorities.

Failure to comply with applicable regulatory requirements may, among other things, result

in fines, suspensions of regulatory approvals, product recalls, product seizures, operating restrictions and criminal prosecution.

Changes in regulatory approval policies during the development

period of any of our product candidates, changes in, or the enactment of, additional regulations or statutes, or changes in regulatory

review practices for a submitted product application may cause a delay in obtaining approval or result in the rejection of an application

for regulatory approval.

Regulatory approval, if obtained, may be made subject

to limitations on the indicated uses for which we may market a product, as well as the approved labeling for the product.

These limitations

could adversely affect our potential product revenue.

Regulatory approval may also be conditioned on costly post-marketing follow-up studies.

In addition, the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping related to the product

will be subject to extensive ongoing regulatory requirements.

Furthermore, for any marketed product, our manufacturer and our manufacturing

facilities will be subject to registration and listing requirements and continual review and periodic inspections by the FDA or other

regulatory authorities.

Failure to comply with applicable regulatory requirements may, among other things, result in fines, suspensions

of regulatory approvals, product recalls, product seizures, operating restrictions and criminal prosecution.

If we encounter difficulties enrolling patients in our clinical

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things, on our ability to enroll a sufficient number of patients, which is a function of many factors, including:

the therapeutic endpoints chosen for evaluation;

the eligibility criteria defined in the protocol;

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

● the therapeutic endpoints chosen

for evaluation;

● 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;

● our ability to obtain and maintain

patient consents;

● competition for patients from

clinical trials for other treatments.

We have experienced and may continue to experience

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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.

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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.

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.

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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

● 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

● 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

● 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

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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.

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

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.

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

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

We must continue to develop manufacturing processes for our

product candidates, and any delay in doing so, or our inability to do so, would result in delays in our clinical trials.

We must continue to develop manufacturing processes for our product

candidates, and any delay in doing so, or our inability to do so, would result in delays in our clinical trials.

The manufacturing processes for our product candidates,

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and product quality issues may arise as we increase the scale of our production.

Any delay or inability in establishing or expanding

our manufacturing capacity could diminish our ability to develop our product candidates.

Any delay or inability in establishing or expanding our

manufacturing capacity could diminish our ability to develop our product candidates.

In the third quarter of 2019, we established our

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We also face potential competition from academic

institutions, government agencies and private and public research institutions engaged in the discovery and development of drugs and

Many of our competitors have significantly greater financial resources and expertise in research and development, preclinical

testing, conducting clinical trials, obtaining regulatory approvals, manufacturing, sales and marketing than we do.

Smaller or early-stage

companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical

institutions, government agencies and private and public research institutions engaged in the discovery and development of drugs and therapies.

Many of our competitors have significantly greater financial resources and expertise in research and development, preclinical testing,

conducting clinical trials, obtaining regulatory approvals, manufacturing, sales and marketing than we do.

Smaller or early-stage companies

may also prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical

In the European Union, potential competition also

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These competitors

also compete with us to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient

registration for clinical trials, as well as to acquire technology and technology licenses complementary to our programs or advantageous

to our business.

Moreover, competitors that are able to achieve patent protection, obtain regulatory approvals and commence commercial

sales of their products before we do, and competitors that have already done so may enjoy a significant competitive advantage.

may not be successful in our efforts to identify or discover additional product candidates.

also compete with us to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration

for clinical trials, as well as to acquire technology and technology licenses complementary to our programs or advantageous to our business.

Moreover, competitors that are able to achieve patent protection, obtain regulatory approvals and commence commercial sales of their products

before we do, and competitors that have already done so may enjoy a significant competitive advantage.

We may not be successful in our efforts to identify or discover

additional product candidates.

Although we intend to utilize our technology to

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For example, our research methodology may not be successful

in identifying potential product candidates, or those we identify may be shown to have harmful side effects or other characteristics

that make them unmarketable or unlikely to receive regulatory approval.

In addition, we may not be able to identify phage that eradicate

the target bacteria, including due to sourcing difficulties such as lack of diversity, inability to obtain samples in a timely manner

or at all, or contamination in the samples.

We may also encounter difficulties in designing phage cocktails that meet the requirements

of an investigational therapy, including due to the build-up of resistances in bacteria to our phage, the range of host bacteria that

are affected by our phage, the variety of activity on different bacteria growth states, issues with toxicity in our phage, and the stability,

robustness and ease of manufacturing of our product candidates.

In addition, the designing of synthetically engineered phage may fail

to result in the development of phage with the desired characteristics or behaviors that are suitable for use as viable therapies, or

may result in phage that contain undesired features such as immunogenicity, toxicity and other safety concerns.

in identifying potential product candidates, or those we identify may be shown to have harmful side effects or other characteristics that

make them unmarketable or unlikely to receive regulatory approval.

In addition, we may not be able to identify phage that eradicate the

target bacteria, including due to sourcing difficulties such as lack of diversity, inability to obtain samples in a timely manner or at

all, or contamination in the samples.

We may also encounter difficulties in designing phage cocktails that meet the requirements of an

investigational therapy, including due to the build-up of resistances in bacteria to our phage, the range of host bacteria that are affected

by our phage, the variety of activity on different bacteria growth states, issues with toxicity in our phage, and the stability, robustness

and ease of manufacturing of our product candidates.

In addition, the designing of synthetically engineered phage may fail to result in

the development of phage with the desired characteristics or behaviors that are suitable for use as viable therapies, or may result in

phage that contain undesired features such as immunogenicity, toxicity and other safety concerns.

A key part of our strategy is to utilize our screening

technology to identify product candidates to pursue in clinical development.

If we fail to identify and develop additional potential

product candidates, we may be unable to grow our business and our results of operations could be materially harmed.

Such product candidates

will require additional, time-consuming development efforts prior to commercial sale, including preclinical studies, clinical trials

and approval by the FDA and/or applicable foreign regulatory agencies.

All product candidates are prone to the risks of failure that

are inherent in pharmaceutical product development.

If we fail to identify and develop additional potential product

candidates, we may be unable to grow our business and our results of operations could be materially harmed.

Such product candidates will

require additional, time-consuming development efforts prior to commercial sale, including preclinical studies, clinical trials and approval

by the FDA and/or applicable foreign regulatory agencies.

All product candidates are prone to the risks of failure that are inherent in

pharmaceutical product development.

Legal requirements as well as ethical and social concerns about

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Additionally, public perception about the safety

and environmental hazards of, and ethical concerns over, synthetic biology and genetic engineering could influence public acceptance

of our technologies, product candidates and processes.

and environmental hazards of, and ethical concerns over, synthetic biology and genetic engineering could influence public acceptance of

our technologies, product candidates and processes.

If we and our collaborators are not able to overcome the legal challenges as well

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may not be accepted.

These challenges and concerns could result in increased expenses, regulatory scrutiny and increased regulation,

trade restrictions on imports of our product candidates, delays or other impediments to our programs or the public acceptance and commercialization

These challenges and concerns could result in increased expenses, regulatory scrutiny and increased regulation, trade

restrictions on imports of our product candidates, delays or other impediments to our programs or the public acceptance and commercialization

of our products.

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For example, we spent significant

time and resources developing our BX001 product candidate, which we have now discontinued.

time and resources developing our BX001 product candidate, which we discontinued.

Our resource allocation decisions may cause us

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development programs and product candidates for specific indications may not yield any commercially viable product candidates.

do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights

not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights

to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous

for us to retain sole development and commercialization rights to the product candidate.

We intend to rely on our new BOLT (BacteriOphage Lead to Treatment)

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.

Our new BOLT platform enables us to rapidly develop,

We intend to continue to rely on our BOLT (BacteriOphage Lead

to Treatment) 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.

Our BOLT platform enables us to rapidly develop,

manufacture and formulate phage therapy candidates targeting particular pathogenic bacteria and incorporates our experience over the past

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initiation in our cystic fibrosis and atopic dermatitis programs.

Our BOLT platform is new 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.

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.

There is a substantial risk of product liability claims in our

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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 candidates;

● delay or failure to complete

our clinical trials;

● withdrawal of clinical trial

participants;

● decreased demand for our product

● injury to our reputation;

● litigation costs;

substantial monetary awards against us;

diversion of management or other resources from key

aspects of our operations.

● substantial monetary awards

diversion of management or other resources from key aspects of our operations.

If we succeed in marketing products, product liability

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insurance policies that cover clinical trials in certain territories.

We intend to expand our insurance coverage to include the sale

of commercial products if marketing approval is obtained for our product candidates or any other compound that we may develop.

insurance coverage is expensive, and we may not be able to maintain insurance coverage at a reasonable cost or at all, and the insurance

coverage that we have or obtain may not be adequate to cover potential claims or losses.

We intend to expand our insurance coverage to include the sale of

commercial products if marketing approval is obtained for our product candidates or any other compound that we may develop.

However, insurance

coverage is expensive, and we may not be able to maintain insurance coverage at a reasonable cost or at all, and the insurance coverage

that we have or obtain may not be adequate to cover potential claims or losses.

Our employees, independent contractors, consultants, commercial

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Misconduct by these parties

could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA and other similar foreign

regulatory bodies, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with

manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent

misconduct laws or report financial information or data accurately or to disclose unauthorized activities to us.

If we obtain FDA approval

of any of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws

will increase significantly, and our costs associated with compliance with such laws are also likely to increase.

These laws may impact,

among other things, our current activities with principal investigators and research patients, as well as proposed and future sales,

marketing and education programs.

could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA and other similar foreign regulatory

bodies, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with manufacturing

standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct

laws or report financial information or data accurately or to disclose unauthorized activities to us.

If we obtain FDA approval of any

of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase

significantly, and our costs associated with compliance with such laws are also likely to increase.

These laws may impact, among other

things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and

education programs.

The FDA and other equivalent foreign regulatory agencies may

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Adverse developments in non-IND human clinical studies

or clinical trials of microbiome products conducted by others may cause the FDA or other oversight bodies to change the requirements

for approval of any of our product candidates.

These regulatory review agencies and committees and the new requirements or guidelines

they promulgate may lengthen the regulatory review process, require us to perform additional studies or trials, increase our development

costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates

or clinical trials of microbiome products conducted by others may cause the FDA or other oversight bodies to change the requirements for

approval of any of our product candidates.

These regulatory review agencies and committees and the new requirements or guidelines they

promulgate may lengthen the regulatory review process, require us to perform additional studies or trials, increase our development costs,

lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates

or lead to significant post-approval limitations or restrictions.

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longer than we otherwise would have expected.

Delays as a result of an increased or lengthier regulatory approval process or further

restrictions on the development of our product candidates can be costly and could negatively impact our ability to complete clinical

trials and commercialize our current and future product candidates in a timely manner if at all.

Delays as a result of an increased or lengthier regulatory approval process or further restrictions

on the development of our product candidates can be costly and could negatively impact our ability to complete clinical trials and commercialize

our current and future product candidates in a timely manner if at all.

Exchange rate fluctuations between the U.S.

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

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 2020, we witnessed a strengthening of the average

exchange rate of the NIS against the U.S.

Dollar, which increased the U.S.

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

Dollar value of Israeli expenses.

If the NIS strengthens against

If the NIS strengthens against the U.S.

Dollar, as it did in 2020 and 2021, the U.S.

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.

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.

Our limited operating history may make it difficult to evaluate

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Since inception in 2015, BiomX Ltd.

substantially all of its resources to developing product candidates with phage technology through its preclinical programs, building

its intellectual property portfolio, developing a supply chain, planning its business, raising capital and providing general and administrative

substantially all of its resources to developing product candidates with phage technology through its preclinical programs, building its

intellectual property portfolio, developing a supply chain, planning its business, raising capital 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 history.

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.

In addition, as an early-stage company, we may

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We may not be successful in such a transition.

We need to grow the size of our organization and may experience

We may need to grow the size of our organization and may experience

difficulties in managing this growth.

As our research, development, manufacturing and

commercialization plans and strategies develop as a public company, we need additional managerial, operational, sales, marketing, financial

and other personnel.

commercialization plans and strategies develop as a public company, we may need additional managerial, operational, sales, marketing,

financial and other personnel.

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

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.

Our future financial performance and our ability

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If we are not able to effectively expand our organization

by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks

necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and

commercialization goals.

by hiring additional employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the

tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development

and commercialization goals.

We are an “emerging growth company,” and we cannot

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and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth

We will remain an emerging growth company until

the earliest of (a) the last day of our fiscal year during which we have generated total annual gross revenue of at least $1.07 billion;

We will remain an emerging growth company until the

earliest of (a) the last day of our fiscal year during which we have generated total annual gross revenue of at least $1.235 billion;

(b) the last day of our fiscal year following the fifth anniversary of the completion of our IPO;

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be a “large accelerated filer” under the Exchange Act.

We shall cease to be an emerging growth company commencing on

January 1, 2024.

Risks Related to Government Regulation

Breakthrough Therapy Designation or Fast Track Designation by

the FDA, even if granted for any of our product candidates developed for therapeutic indications, may not lead to a faster development,

regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing

approval in the United States.

In the United States, we may seek a Breakthrough

Therapy Designation for some of our product candidates, including BX003 or our cystic fibrosis product candidate under development.

breakthrough therapy is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious

or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement

over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical

For therapies that have been designated as breakthrough therapies, interaction and communication between the FDA and the

sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed

in ineffective control regimens.

Breakthrough Therapy Designation or Fast Track Designation by the

FDA, even if granted for any of our product candidates developed for therapeutic indications, may not lead to a faster development, regulatory

review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval

in the United States.

In the United States, we may seek a Breakthrough Therapy Designation for

some of our product candidates, including BX004 or another product candidate under development.

A breakthrough therapy is defined as a

therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or

condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies

on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

For therapies

that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help

to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

Breakthrough designation also provides sponsors with the potential for rolling review of a BLA.

as a breakthrough therapy is within the discretion of the FDA.

Designation as a breakthrough therapy

is within the discretion of the FDA.

In the European Union, the PRIME (PRIority MEdicines)

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the relevant EMA scientific committees and, possibly, some payors and thus reinforces the EMA’s scientific and regulatory support.

The PRIME status, which is granted at the EMA’s discretion, focuses on medicinal products the marketing authorization of which

qualifies for accelerated assessment (medicinal products of major interest from a public health perspective, in particular from a therapeutic

innovation perspective).

The PRIME status, which is granted at the EMA’s discretion, focuses on medicinal products the marketing authorization of which qualifies

for accelerated assessment (medicinal products of major interest from a public health perspective, in particular from a therapeutic innovation

perspective).

Accordingly, even if we believe one of our product

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In any event, the receipt of a Breakthrough Therapy Designation or PRIME status for

a product candidate may not actually result in a faster development process, review or approval compared to therapies considered for

approval under conventional procedures and does not assure ultimate approval.

In addition, even if one or more of our product candidates

qualify as breakthrough therapies or is granted PRIME status, the FDA or EMA, respectively, may later decide that such product candidates

no longer meet the conditions for qualification or decide that the time period for review or approval will not be shortened.

a product candidate may not actually result in a faster development process, review or approval compared to therapies considered for approval

under conventional procedures and does not assure ultimate approval.

In addition, even if one or more of our product candidates qualify

as breakthrough therapies or is granted PRIME status, the FDA or EMA, respectively, may later decide that such product candidates no longer

meet the conditions for qualification or decide that the time period for review or approval will not be shortened.

In the United States, we may seek Fast Track Designation

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is withdrawn if it becomes negative.

Moreover, under the centralized procedure, the European Commission may grant “conditional

marketing authorizations” in cases where all the required safety and efficacy data are not yet available.

The conditional marketing

authorization is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures.

for one year and has to be renewed annually until fulfillment of all the conditions.

If the conditions are not fulfilled within the timeframe

set by the EMA, the marketing authorization ceases to be renewed.

As with Fast Track Designation, the competent regulatory authorities

in the European Union have broad discretion whether or not to grant such an accelerated assessment or approval and, even if such assessment

or approval is granted, we may not experience a faster development process, review or approval compared to conventional procedures.

We may fail to obtain and maintain orphan drug designations

from the FDA or equivalent foreign regulatory agencies for our current and future therapeutic product candidates, as applicable.

Moreover, under the centralized procedure, the European Commission may grant “conditional marketing

authorizations” in cases where all the required safety and efficacy data are not yet available.

The conditional marketing authorization

is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures.

It is valid for one year

and has to be renewed annually until fulfillment of all the conditions.

If the conditions are not fulfilled within the timeframe set by

the EMA, the marketing authorization ceases to be renewed.

As with Fast Track Designation, the competent regulatory authorities in the

European Union have broad discretion whether or not to grant such an accelerated assessment or approval and, even if such assessment or

approval is granted, we may not experience a faster development process, review or approval compared to conventional procedures.

We may fail to obtain and maintain orphan drug designations from

the FDA or equivalent foreign regulatory agencies for our current and future therapeutic product candidates, as applicable.

In the United States, under the Orphan Drug Act,

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occurring in a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United

States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the

United States.

In the United States, the orphan drug designation entitles a party to financial incentives, such as opportunities for

grant funding toward clinical trial costs, tax advantages and user-fee waivers.

In addition, if a product that has the orphan drug designation

subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug

exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug or biologic for

the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan

drug exclusivity or where the original manufacturer is unable to assure sufficient product quantity.

States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United

In the United States, the orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding

toward clinical trial costs, tax advantages and user-fee waivers.

In addition, if a product that has the orphan drug designation subsequently

receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity,

which means that the FDA may not approve any other applications, including an NDA, to market the same drug or biologic for the same indication

for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity

or where the original manufacturer is unable to assure sufficient product quantity.

In addition, exclusive marketing rights in the

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the necessary investment in developing the drug or biological product.

The granting of the orphan designation requires that there is

no satisfactory method of diagnosis, prevention or treatment, or, if such a method exists, that the future medicine is to be of significant

The granting of the orphan designation requires that there is no

satisfactory method of diagnosis, prevention or treatment, or, if such a method exists, that the future medicine is to be of significant

benefit to those affected by the condition.

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Maintenance of the orphan designation at the time of marketing authorization means that all the drugs/biologicals

authorized since the granting of the designation become relevant for determining the lack of satisfactory therapy or the significant

authorized since the granting of the designation become relevant for determining the lack of satisfactory therapy or the significant benefit.

If obtained, the orphan drug designation would

entitle us to financial incentives, such as reductions of fees or fee waivers and 10 years of market exclusivity.

Market exclusivity

precludes the EMA or the national competent authorities from validating a marketing authorization application, and the European Commission

or a national competent authority from granting a marketing authorization, for a same or similar drug/biological and the same therapeutic

The 10-year period may be reduced to six years if the orphan designation criteria are no longer met, including where it is

shown that the product is not sufficiently profitable to justify maintenance of market exclusivity.

The orphan exclusivity may also be

lost vis-à-vis another drug/biological in cases where the manufacturer is unable to assure sufficient quantity of the drug to

meet patient needs or if that other product is proved to be clinically superior to the approved orphan product.

A drug/biological is

clinically superior if it is safer, more effective or makes a major contribution to patient care.

Market exclusivity precludes

the EMA or the national competent authorities from validating a marketing authorization application, and the European Commission or a

national competent authority from granting a marketing authorization, for a same or similar drug/biological and the same therapeutic indication.

The 10-year period may be reduced to six years if the orphan designation criteria are no longer met, including where it is shown that

the product is not sufficiently profitable to justify maintenance of market exclusivity.

The orphan exclusivity may also be lost vis-à-vis

another drug/biological in cases where the manufacturer is unable to assure sufficient quantity of the drug to meet patient needs or if

that other product is proved to be clinically superior to the approved orphan product.

A drug/biological is clinically superior if it

is safer, more effective or makes a major contribution to patient care.

Even if we receive regulatory approval of any product candidates

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result in significant additional expense.

Additionally, any of our product candidates, if approved, could be subject to labeling and

other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience

Additionally, any of our product candidates, if approved, could be subject to labeling and other

restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience

unanticipated problems with our product candidates.

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advertising, promotion, sampling, recordkeeping, export, import, conduct of post-marketing studies and submission of safety, efficacy

and other post-market information, including both federal and state requirements in the United States and requirements of equivalent

foreign regulatory agencies.

In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical

trials that we conduct post-approval.

and other post-market information, including both federal and state requirements in the United States and requirements of equivalent foreign

regulatory agencies.

In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that

we conduct post-approval.

Manufacturers and manufacturers’ facilities

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Other potential consequences include, among other things:

restrictions on the marketing or manufacturing of our

products, withdrawal of products from the market, or voluntary or mandatory product recalls;

fines, warning or untitled enforcement letters, or

holds on clinical trials;

refusal by the FDA or equivalent foreign regulatory

agencies to approve pending applications or supplements to approved applications filed by us or the suspension or revocation of license

product seizure or detention or refusal to permit the

import or export of our product candidates;

injunctions or the imposition of civil or criminal

● restrictions on the marketing

or manufacturing of our products, withdrawal of products from the market, or voluntary or mandatory product recalls;

● fines, warning or untitled enforcement

letters, or holds on clinical trials;

● refusal by the FDA or equivalent

foreign regulatory agencies to approve pending applications or supplements to approved applications filed by us or the suspension or

revocation of license approvals;

● product seizure or detention

or refusal to permit the import or export of our product candidates;

● injunctions or the imposition

of civil or criminal penalties.

The FDA or equivalent foreign regulatory agencies

strictly regulate the marketing, labeling, advertising and promotion of drug products that are placed on the market.

Products may be

promoted only for the approved indications and in accordance with the provisions of the approved label or other regulatory marketing

The FDA and equivalent foreign regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label

uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

The policies of

the FDA or equivalent foreign regulatory agencies may change, and additional government regulations may be enacted that could prevent,

limit or delay regulatory approval of our product candidates.

If we are slow or unable to adapt to changes in existing requirements or

the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval

that we may have obtained, which would adversely affect our business, prospects and the ability to achieve or sustain profitability.

The policies of the FDA or equivalent foreign regulatory agencies may

change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative

or executive action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements or the

adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action,

and we may not achieve or sustain profitability.

Products may be promoted

only for the approved indications and in accordance with the provisions of the approved label or other regulatory marketing pathway.

FDA and equivalent foreign regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses,

and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

The policies of the FDA

or equivalent foreign regulatory agencies may change, and additional government regulations may be enacted that could prevent, limit or

delay regulatory approval of our product candidates.

If we are slow or unable to adapt to changes in existing requirements or the adoption

of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may

have obtained, which would adversely affect our business, prospects and the ability to achieve or sustain profitability.

The policies of the FDA or equivalent foreign regulatory

agencies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our

product candidates.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation

or administrative or executive action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing

requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject

to enforcement action, and we may not achieve or sustain profitability.

Noncompliance by us or any future collaborator

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products vary widely from country to country.

As a result, we might obtain regulatory approval for a product in a particular country

but then be subject to pricing regulations in that country that delay the commercial launch of the product and negatively impact the

revenue we are able to generate from the sale of the product in that country.

In addition, our ability to commercialize any approved

products successfully will depend in part on the extent to which reimbursement for these products will be available from government health

administration authorities, private health insurers and other organizations.

Even if we succeed in bringing one or more therapeutic products

to market, these products may not be considered cost-effective, and the amount reimbursed for any products may be insufficient to allow

us to sell them on a competitive basis.

If the price we are able to charge for therapeutic products is inadequate in light of our development

and other costs, our future profitability could be adversely affected.

As a result, we might obtain regulatory approval for a product in a particular country but

then be subject to pricing regulations in that country that delay the commercial launch of the product and negatively impact the revenue

we are able to generate from the sale of the product in that country.

In addition, our ability to commercialize any approved products

successfully will depend in part on the extent to which reimbursement for these products will be available from government health administration

authorities, private health insurers and other organizations.

Even if we succeed in bringing one or more therapeutic products to market,

these products may not be considered cost-effective, and the amount reimbursed for any products may be insufficient to allow us to sell

them on a competitive basis.

If the price we are able to charge for therapeutic products is inadequate in light of our development and

other costs, our future profitability could be adversely affected.

Ongoing health care legislative and regulatory reform measures

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coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Since its enactment, there have been judicial, executive and Congressional

challenges to certain aspects of the ACA.

Since its enactment, there have been judicial,

executive and Congressional challenges to certain aspects of the ACA.

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the

ACA without specifically ruling on the constitutionality of the ACA.

Prior to the Supreme Court’s decision, President Biden issued

an executive order initiating a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health

insurance coverage through the ACA marketplace.

The executive order also instructed certain governmental agencies to review and reconsider

their existing policies and rules that limit access to healthcare.

More recently, on March 11, 2021, President Biden signed the American

Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average

manufacturer price, beginning January 1, 2024.

It is unclear how other healthcare reform measures of the Biden administration, if any,

will impact our business.

Supreme Court dismissed the most recent

judicial challenge to the ACA without specifically ruling on the constitutionality of the ACA.

Prior to the Supreme Court’s decision,

President Biden issued an executive order initiating a special enrollment period from February 15, 2021 through August 15, 2021 for purposes

of obtaining health insurance coverage through the ACA marketplace.

The executive order also instructed certain governmental agencies

to review and reconsider their existing policies and rules that limit access to healthcare.

More recently, on March 11, 2021, President

Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at

100% of a drug’s average manufacturer price, beginning January 1, 2024.

It is unclear how other healthcare reform measures of the

Biden administration, if any, will impact our business.

These laws and future state and federal health

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that traditionally granted high prices.

Disruptions 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

Disruptions 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.

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Violations of Trade Laws can result in substantial

criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and

fraud litigation, reputational harm, and other consequences.

We have direct or indirect interactions with officials and employees of

government agencies or government-affiliated hospitals, universities and other organizations.

criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud

litigation, reputational harm, and other consequences.

We have direct or indirect interactions with officials and employees of government

agencies or government-affiliated hospitals, universities and other organizations.

We also expect our non-U.S.

to increase over time.

We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations

and other regulatory approvals, and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners,

activities to increase

We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and

other regulatory approvals, and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners,

even if we do not explicitly authorize or have prior knowledge of such activities.

Risks Related to our Licensed and Co-Owned Intellectual Property

The license agreements we maintain, including the Yeda 2015

License Agreement, with Yeda are important to our business.

If we or the other parties to our license agreements fail to adequately perform

under the license agreements, or if we or they terminate the license agreements, the development, testing, manufacture, production and

sale of our phage-based therapeutic product candidates would be delayed or terminated, and our business would be adversely affected.

The license agreements we maintain, including the Yeda 2015 License

Agreement, with Yeda are important to our business.

If we or the other parties to our license agreements fail to adequately perform under

the license agreements, or if we or they terminate the license agreements, the development, testing, manufacture, production and sale

of our phage-based therapeutic product candidates would be delayed or terminated, and our business would be adversely affected.

The Yeda 2015 License Agreement provides for an

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The License Agreement terminates upon the later of the expiration of

the last of the patents covered under the License Agreement and the expiry of a continuous 15-year period during which there has not

been a first commercial sale of any product in any country.

Yeda may also terminate the agreement if we fail to observe certain diligence

and development requirements and milestones as described in the License Agreement.

the last of the patents covered under the License Agreement and the expiry of a continuous 15-year period during which there has not been

a first commercial sale of any product in any country.

Yeda may also terminate the agreement if we fail to observe certain diligence and

development requirements and milestones as described in the License Agreement.

we or Yeda may terminate the agreement for the material

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other similar discontinuation of business.

Upon termination of the agreement, other than due to the passage of time, we are required

to grant to Yeda a nonexclusive, irrevocable, perpetual, fully paid-up, sublicensable, worldwide license in respect of our rights in

know-how and research results as described in the Yeda 2015 License Agreement, provided that, if Yeda subsequently grants a license to

a third party that utilizes our rights, we are entitled to share in the net proceeds actually received by Yeda arising out of that license,

subject to a cap based on the development expenses that we incur in connection with the License Agreement.

For more information on the

License Agreement, see “ Business—Material Agreements—License Agreements—License Agreement with Yeda.

Upon termination of the agreement, other than due to the passage of time, we are required to

grant to Yeda a nonexclusive, irrevocable, perpetual, fully paid-up, sublicensable, worldwide license in respect of our rights in know-how

and research results as described in the Yeda 2015 License Agreement, provided that, if Yeda subsequently grants a license to a third

party that utilizes our rights, we are entitled to share in the net proceeds actually received by Yeda arising out of that license, subject

to a cap based on the development expenses that we incur in connection with the License Agreement.

For more information on the License

Agreement, see “ Business—Material Agreements—License Agreements—License Agreement with Yeda.

We also maintain additional license agreements:

with Keio and JSR, pursuant to which we were granted

an exclusive, royalty-bearing, worldwide, perpetual sublicense by JSR to certain patent rights related to our IBD program.

Specifically,

these patent rights relate to bacterial targets that have been observed to be related to IBD and the phage that were observed to

eradicate these bacterial targets;

with Keio and JSR, pursuant to which we were granted

an exclusive, royalty-bearing, worldwide, perpetual sublicense by JSR to certain patent rights related to PSC program.

Specifically,

these patent rights relate to bacterial targets that have been observed to be related to PSC and the phage that were observed to

eradicate these bacterial targets.

with Keio and JSR, pursuant to which we were granted an exclusive, royalty-bearing, worldwide, perpetual sublicense by JSR to certain patent rights related to our IBD program.

Specifically, these patent rights relate to bacterial targets that have been observed to be related to IBD and the phage that were observed to eradicate these bacterial targets;

with Keio and JSR, pursuant to which we were granted an exclusive, royalty-bearing, worldwide, perpetual sublicense by JSR to certain patent rights related to PSC program.

Specifically, these patent rights relate to bacterial targets that have been observed to be related to PSC and the phage that were observed to eradicate these bacterial targets.

Termination of the license agreements could cause

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Keio and JSR provide licenses to patents related to, among other things, IBD and PSC programs.

Pursuant to these license agreements,

we are required to pay annual license fees, as well as a contingent consideration comprised of milestone and royalty payments, which

depend on the achievement of future milestones and potential revenue from products.

Pursuant to these license agreements, we

are required to pay annual license fees, as well as a contingent consideration comprised of milestone and royalty payments, which depend

on the achievement of future milestones and potential revenue from products.

If we fail to comply with our obligations under

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under our license agreements if we do not meet our contractual obligations.

Such an occurrence could materially adversely affect the

value of our products being developed under any such license agreements.

Such an occurrence could materially adversely affect the value

of our products being developed under any such license agreements.

Termination of one or more of our license agreements, or reduction

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As a result, any such third party may have certain rights to such intellectual property.

In addition, subject to the terms of any such

license agreements, we may not have the right to control the preparation, filing, prosecution and maintenance, and we may not have the

right to control the enforcement and defense, of patents and patent applications covering the technology that we license from third parties.

We cannot be certain that our in-licensed patent applications (and any patents issuing therefrom) that are controlled by our licensors

will be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with the best interests of our business.

If our licensors fail to prosecute, maintain, enforce and defend such patents rights, or lose rights to those patent applications (or

any patents issuing therefrom), the rights we have licensed may be reduced or eliminated, our right to develop and commercialize any

of our product candidates and proprietary product platform technology that are subject of such licensed rights could be adversely affected,

and we may not be able to prevent competitors from making, using and selling competing products.

Moreover, we cannot be certain that

such activities by our potential future licensors will be conducted in compliance with applicable laws and regulations or will result

in valid and enforceable patents or other intellectual property rights.

In addition, even where we may have the right to control the

prosecution of patents and patent applications that we may license to and from third parties, we may still be adversely affected or prejudiced

by actions or inactions of our potential future licensees, licensors and their counsel that took place prior to the date of assumption

of control over patent prosecution.

In addition, subject to the terms of any such license

agreements, we may not have the right to control the preparation, filing, prosecution and maintenance, and we may not have the right to

control the enforcement and defense, of patents and patent applications covering the technology that we license from third parties.

cannot be certain that our in-licensed patent applications (and any patents issuing therefrom) that are controlled by our licensors will

be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with the best interests of our business.

licensors fail to prosecute, maintain, enforce and defend such patents rights, or lose rights to those patent applications (or any patents

issuing therefrom), the rights we have licensed may be reduced or eliminated, our right to develop and commercialize any of our product

candidates and proprietary product platform technology that are subject of such licensed rights could be adversely affected, and we may

not be able to prevent competitors from making, using and selling competing products.

Moreover, we cannot be certain that such activities

by our potential future licensors will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable

patents or other intellectual property rights.

In addition, even where we may have the right to control the prosecution of patents and

patent applications that we may license to and from third parties, we may still be adversely affected or prejudiced by actions or inactions

of our potential future licensees, licensors and their counsel that took place prior to the date of assumption of control over patent

The patent position of biopharmaceutical companies,

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validity challenge could be an alleged failure to meet any of several statutory patentability requirements, including lack of novelty,

obviousness, non-enablement, failure to meet the written description requirement, indefiniteness, and/or failure to claim patentable

subject matter.

Grounds for an unenforceability assertion could be an allegation that someone connected to prosecution of the patent/s

at issue intentionally withheld material information from the USPTO or made a misleading statement during prosecution.

Additional grounds

for an unenforceability assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect

inventorship with deceptive intent.

obviousness, non-enablement, failure to meet the written description requirement, indefiniteness, and/or failure to claim patentable subject

Grounds for an unenforceability assertion could be an allegation that someone connected to prosecution of the patent/s at issue

intentionally withheld material information from the USPTO or made a misleading statement during prosecution.

Additional grounds for an

unenforceability assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect inventorship

with deceptive intent.

Third parties may also raise similar claims before the USPTO, even outside the context of litigation.

The outcome of any assertion of invalidity and/or unenforceability is unpredictable.

If a defendant or third party were to prevail on

a legal assertion of invalidity and/or unenforceability, We and our licensors would lose at least part, and perhaps all, of the claims

of the challenged patent/s.

of any assertion of invalidity and/or unenforceability is unpredictable.

If a defendant or third party were to prevail on a legal assertion

of invalidity and/or unenforceability, We and our licensors would lose at least part, and perhaps all, of the claims of the challenged

Such a loss of patent protection could have a material adverse impact on our business.

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ability to commercialize products could suffer.

Our commercial success will depend in part on

our ability to obtain and maintain patent protection sufficient to prevent others from marketing our product candidates, as well as to

defend and enforce these patents against infringement and to operate without infringing the proprietary rights of others.

of our product candidates from unauthorized use by third parties will depend on having valid and enforceable patents that cover our product

candidates or their manufacture or use or on having effective trade secret protection.

If our patent applications do not result in issued

patents or if our patents are found to be invalid, we will lose the ability to exclude others from making, using or selling the inventions

claimed therein.

Our commercial success will depend in part on our

ability to obtain and maintain patent protection sufficient to prevent others from marketing our product candidates, as well as to defend

and enforce these patents against infringement and to operate without infringing the proprietary rights of others.

Protection of our product

candidates from unauthorized use by third parties will depend on having valid and enforceable patents that cover our product candidates

or their manufacture or use or on having effective trade secret protection.

If our patent applications do not result in issued patents

or if our patents are found to be invalid, we will lose the ability to exclude others from making, using or selling the inventions claimed

We have a limited number of patents and pending patent applications.

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can be uncertain and involve complex legal and factual questions.

This is due to inconsistent application of policies and changes in

policy relating to the examination and enforcement of biotechnology patents to date on a global scale.

The laws of some countries may

not protect intellectual property rights to the same extent as the laws of countries having well-established patent systems, and those

countries may lack adequate rules and procedures for defending our intellectual property rights.

Also, changes in either patent laws

or in the interpretations of patent laws may diminish the value of our intellectual property.

We are not able to guarantee that all of

our patent applications will result in the issuance of patents, and we cannot predict the breadth of claims that may be allowed in our

patent applications or in the patent applications we may license from others.

Central provisions of The Leahy-Smith America

Invents Act, or the America Invents Act, went into effect on September 16, 2012 and on March 16, 2013.

The America Invents Act includes

a number of significant changes to U.S.

These changes include provisions that affect the way patent applications are being

filed, prosecuted and litigated.

For example, the America Invents Act enacted proceedings involving post-issuance patent review procedures,

such as inter partes review, or IPR, and post-grant review, that allow third parties to challenge the validity of an issued patent in

front of the USPTO Patent Trial and Appeal Board.

Each proceeding has different eligibility criteria and different patentability challenges

that can be raised.

IPRs permit any person (except a party who has been litigating the patent for more than a year) to challenge the

validity of the patent on the grounds that it was anticipated or made obvious by prior art.

Patents covering pharmaceutical products

have been subject to attack in IPRs from generic drug companies and from hedge funds.

If it is within nine months of the issuance of

the challenged patent, a third party can petition the USPTO for post-grant review, which can be based on any invalidity grounds and is

not limited to prior art patents or printed publications.

In post-issuance proceedings, USPTO rules and

regulations generally tend to favor patent challengers over patent owners.

For example, unlike in district court litigation, claims challenged

in post-issuance proceedings are given their broadest reasonable meaning, which increases the chance a claim might be invalidated by

prior art or lack support in the patent specification.

As another example, unlike in district court litigation, there is no presumption

of validity for an issued patent, and thus a challenger’s burden to prove invalidity is by a preponderance of the evidence, as

opposed to the heightened clear and convincing evidence standard.

As a result of these rules and others, statistics released by the USPTO

show a high percentage of claims being invalidated in post-issuance proceedings.

Moreover, with few exceptions, there is no standing

requirement to petition the USPTO for inter partes review or post-grant review.

In other words, companies that have not been charged

with infringement or that lack commercial interest in the patented subject matter can still petition the USPTO for review of an issued

Thus, even where we have issued patents, our rights under those patents may be challenged and ultimately not provide us with

sufficient protection against competitive products or processes.

This is due to inconsistent application of policies and changes in policy

relating to the examination and enforcement of biotechnology patents to date on a global scale.

The laws of some countries may not protect

intellectual property rights to the same extent as the laws of countries having well-established patent systems, and those countries may

lack adequate rules and procedures for defending our intellectual property rights.

Also, changes in either patent laws or in the interpretations

of patent laws may diminish the value of our intellectual property.

We are not able to guarantee that all of our patent applications will

result in the issuance of patents, and we cannot predict the breadth of claims that may be allowed in our patent applications or in the

patent applications we may license from others.

The Leahy-Smith America Invents Act, or the America

Invents Act, provides for proceedings involving post-issuance patent review procedures, such as inter partes review, or IPR, and post-grant

review, that allow third parties to challenge the validity of an issued patent in front of the USPTO Patent Trial and Appeal Board.

proceeding has different eligibility criteria and different patentability challenges that can be raised.

IPRs permit any person (except

a party who has been litigating the patent for more than a year) to challenge the validity of the patent on the grounds that it was anticipated

or made obvious by prior art.

Patents covering pharmaceutical products have been subject to attack in IPRs from generic drug companies

and from hedge funds.

If it is within nine months of the issuance of the challenged patent, a third party can petition the USPTO for post-grant

review, which can be based on any invalidity grounds and is not limited to prior art patents or printed publications.

In post-issuance proceedings, USPTO rules and regulations

generally tend to favor patent challengers over patent owners.

For example, unlike in district court litigation, claims challenged in

post-issuance proceedings are given their broadest reasonable meaning, which increases the chance a claim might be invalidated by prior

art or lack support in the patent specification.

As another example, unlike in district court litigation, there is no presumption of validity

for an issued patent, and thus a challenger’s burden to prove invalidity is by a preponderance of the evidence, as opposed to the

heightened clear and convincing evidence standard.

As a result of these rules and others, statistics released by the USPTO show a high

percentage of claims being invalidated in post-issuance proceedings.

Moreover, with few exceptions, there is no standing requirement to

petition the USPTO for inter partes review or post-grant review.

In other words, companies that have not been charged with infringement

or that lack commercial interest in the patented subject matter can still petition the USPTO for review of an issued patent.

where we have issued patents, our rights under those patents may be challenged and ultimately not provide us with sufficient protection

against competitive products or processes.

The degree of future protection for our proprietary

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or keep our competitive advantage.

we might not be the first to file patent applications

for our inventions;

others may independently develop similar or alternative

product candidates to any of our product candidates that fall outside the scope of our patents;

our pending patent applications may not result in issued

our issued patents may not provide a basis for commercially

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.

● we might not be the first to

file patent applications for our inventions;

● others may independently develop

similar or alternative product candidates to any of our product candidates that fall outside the scope of our patents;

● our pending patent applications

may not result in issued patents;

● our issued patents may not provide

a basis for commercially 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.

An issued patent does not guarantee us the right

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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

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.

If we do not prevail in such disputes, we may

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The resolution of any contract interpretation disagreement that may arise could narrow what we believe to

be the scope of our rights to the relevant intellectual property or technology or could increase what we believe to be our financial

or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition,

be the scope of our rights to the relevant intellectual property or technology or could increase what we believe to be our financial or

other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition,

results of operations and prospects.

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patents subject to those agreements, and, if the license agreements are terminated, we may be subject to litigation by the licensor.

Litigation could result in substantial costs to us and distract our management.

If we do not prevail, we may be required to pay damages,

including treble damages, attorneys’ fees, costs and expenses and royalties.

We may also be enjoined from selling our products

or services, which could adversely affect our ability to offer products or services, our ability to continue operations, and our financial

could result in substantial costs to us and distract our management.

If we do not prevail, we may be required to pay damages, including

treble damages, attorneys’ fees, costs and expenses and royalties.

We may also be enjoined from selling our products or services,

which could adversely affect our ability to offer products or services, our ability to continue operations, and our financial condition.

If we infringe the rights of third parties, we could be prevented

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or can be amended to provide support for a claim that results in an issued patent that is infringed by one or more of our products.

such a case, others may assert infringement claims against us, and should we be found to infringe these patents or impermissibly use

their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully

infringed on such third parties’ patent rights.

such a case, others may assert infringement claims against us, and should we be found to infringe these patents or impermissibly use their

intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed

on such third parties’ patent rights.

In addition to any damages we might have to pay,

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pursue claims against third parties that infringe on our licensed or co-owned technology.

Thus, our licensed and co-owned technology

may not provide adequate protection against competitors.

Thus, our licensed and co-owned technology may

not provide adequate protection against competitors.

The pharmaceutical industry is characterized by

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relating to our licensed and/or co-owned intellectual property rights, even if resolved in our favor, could be substantial.

litigation would divert our management efforts, and we may not have sufficient resources to bring any such action to a successful conclusion.

Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue operations.

Any such litigation

would divert our management efforts, and we may not have sufficient resources to bring any such action to a successful conclusion.

Uncertainties

resulting from the initiation and continuation of any litigation could limit our ability to continue operations.

Additionally, because our pipeline may involve

additional development candidates that could require the use of proprietary rights held by third parties, the growth of our business

could depend in part on our ability to acquire, in-license or use these proprietary rights.

In addition, our development candidates may

require specific formulations to work effectively and efficiently and these rights may be held by others.

We may be unable to acquire

or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we

The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established

companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive.

These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development

and commercialization capabilities.

additional development candidates that could require the use of proprietary rights held by third parties, the growth of our business could

depend in part on our ability to acquire, in-license or use these proprietary rights.

In addition, our development candidates may require

specific formulations to work effectively and efficiently and these rights may be held by others.

We may be unable to acquire or in-license

any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify.

licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies

are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive.

These established

companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization

capabilities.

For example, we sometimes collaborate with U.S.

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the intellectual property rights to other parties, potentially blocking our ability to pursue our program.

In addition, companies that perceive us to be

a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual

property rights on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully obtain

rights to require third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

In addition, companies that perceive us to be a

competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual property

rights on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully obtain rights to

require third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

We may not be successful in obtaining, through acquisitions,

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property, through licenses from third parties, to develop our product candidates and proprietary product platform technologies.

healthcare companies and academic institutions are competing with us in the field of microbiome therapies and may have patents and/or

have filed and are likely filing patent applications potentially relevant to our business.

In order to avoid infringing these third-party

patents, we may find it necessary or prudent to obtain licenses to such patents from such third-party intellectual property holders.

We may also require licenses from third parties for certain technologies that we may be evaluating for use with our current or future

product candidates.

However, we may be unable to secure such licenses or otherwise acquire or in-license any compositions, methods of

use, processes or other intellectual property rights from third parties that we identify as necessary for our current or future product

candidates and our proprietary product platform at a reasonable cost or on reasonable terms, if at all.

The licensing or acquisition

of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license

or acquire third-party intellectual property rights that we may consider attractive or necessary.

These established companies may have

a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

We also may be unable

to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment

Some healthcare

companies and academic institutions are competing with us in the field of microbiome therapies and may have patents and/or have filed

and are likely filing patent applications potentially relevant to our business.

In order to avoid infringing these third-party patents,

we may find it necessary or prudent to obtain licenses to such patents from such third-party intellectual property holders.

require licenses from third parties for certain technologies that we may be evaluating for use with our current or future product candidates.

However, we may be unable to secure such licenses or otherwise acquire or in-license any compositions, methods of use, processes or other

intellectual property rights from third parties that we identify as necessary for our current or future product candidates and our proprietary

product platform at a reasonable cost or on reasonable terms, if at all.

The licensing or acquisition of third-party intellectual property

rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual

property rights that we may consider attractive or necessary.

These established companies may have a competitive advantage over us due

to their size, capital resources and greater clinical development and commercialization capabilities.

In addition, companies that perceive

us to be a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third-party intellectual

property rights on terms that would allow us to make an appropriate return on our investment or at all.

In the event that we try to obtain rights to required

third-party intellectual property rights and is ultimately unsuccessful, we may be required to expend significant time and resources

to redesign our technology, product candidates or the methods for manufacturing them or to develop or license replacement technology,

all of which may not be feasible on a technical or commercial basis.

third-party intellectual property rights and is ultimately unsuccessful, we may be required to expend significant time and resources to

redesign our technology, product candidates or the methods for manufacturing them or to develop or license replacement technology, all

of which may not be feasible on a technical or commercial basis.

If we are unable to do so, we may be unable to develop or commercialize

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information to strengthen our competitive position.

We consider know-how to be our primary intellectual property with respect to our

proprietary product platform.

Our clinical trials allow us to collect clinical data, which we use as a feedback loop to make improvements

to our proprietary product platform.

In particular, we anticipate that, with respect to this proprietary product platform, this data

may over time be disseminated within the industry through independent development, the publication of journal articles describing the

method and the movement of skilled personnel.

We consider know-how to be our primary intellectual property with respect to our proprietary

product platform.

Our clinical trials allow us to collect clinical data, which we use as a feedback loop to make improvements to our proprietary

product platform.

In particular, we anticipate that, with respect to this proprietary product platform, this data may over time be disseminated

within the industry through independent development, the publication of journal articles describing the method and the movement of skilled

We cannot rule out that our competitors may have

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of our technology, including our proprietary processes for manufacturing and purifying bacteriophage.

Trade secrets are difficult to

protect, especially in the pharmaceutical industry, where much of the information about a product must be made public during the regulatory

approval process.

Trade secrets are difficult to protect,

especially in the pharmaceutical industry, where much of the information about a product must be made public during the regulatory approval

Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific

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In addition, courts outside the United States may be less willing to or may not protect trade secrets.

Moreover, our competitors may

independently develop equivalent knowledge, methods and know-how.

Moreover, our competitors may independently

develop equivalent knowledge, methods and know-how.

If we are sued for infringing intellectual property rights of

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In addition, because patent applications can

take many years to issue, there may be currently pending patent applications, unknown to us, that may later result in issued patents

that our product candidates may infringe or that may trigger an interference proceeding regarding one of our owned or licensed patents

or applications.

There could also be existing patents of which we are not aware that our product candidates may inadvertently infringe

or that may become involved in an interference proceeding.

take many years to issue, there may be currently pending patent applications, unknown to us, that may later result in issued patents that

our product candidates may infringe or that may trigger an interference proceeding regarding one of our owned or licensed patents or applications.

There could also be existing patents of which we are not aware that our product candidates may inadvertently infringe or that may become

involved in an interference proceeding.

The biotechnology and pharmaceutical industries

are characterized by the existence of a large number of patents and frequent litigation based on allegations of patent infringement.

For so long as our product candidates are in clinical trials, we believe our clinical activities fall within the scope of the exemptions

provided by 35 U.S.C.

Section 271(e) in the United States, which exempts from patent infringement liability activities reasonably related

to the development and submission of information to the FDA.

As our clinical investigational drug product candidates progress toward

commercialization, the possibility of a patent infringement claim against us increases.

While we attempt to ensure that our active clinical

investigational drugs and the methods we employ to manufacture them, as well as the methods for their use we intend to promote, do not

infringe other parties’ patents and other proprietary rights, we cannot be certain they do not, and competitors or other parties

may assert that we infringe their proprietary rights in any event.

so long as our product candidates are in clinical trials, we believe our clinical activities fall within the scope of the exemptions provided

Section 271(e) in the United States, which exempts from patent infringement liability activities reasonably related to the

development and submission of information to the FDA.

As our clinical investigational drug product candidates progress toward commercialization,

the possibility of a patent infringement claim against us increases.

While we attempt to ensure that our active clinical investigational

drugs and the methods we employ to manufacture them, as well as the methods for their use we intend to promote, do not infringe other

parties’ patents and other proprietary rights, we cannot be certain they do not, and competitors or other parties may assert that

we infringe their proprietary rights in any event.

We may be exposed to future litigation based on

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to demonstrate that the manufacturing processes we employ and the use of our product candidates do not infringe third-party patents.

If third-party patents were found to cover our product candidates or their use or manufacture, we could be required to pay damages or

be enjoined and therefore unable to commercialize our product candidates, unless we obtained a license.

A license may not be available

to us on acceptable terms, if at all.

third-party patents were found to cover our product candidates or their use or manufacture, we could be required to pay damages or be

enjoined and therefore unable to commercialize our product candidates, unless we obtained a license.

A license may not be available to

us on acceptable terms, if at all.

We may become subject to claims for remuneration or royalties

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has been developed by our employees in the course of their employment for us.

Under the Israeli Patent Law, 5727-1967, or the Patent

Law, inventions conceived by an employee during the term and as part of the scope of his or her employment with a company are regarded

as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving

the employee service invention rights.

The Patent Law also provides that, if there is no such agreement between an employer and an employee,

the Israeli Compensation and Royalties Committee, or the Committee, a body constituted under the Patent Law, shall determine whether

the employee is entitled to remuneration for his or her inventions.

We generally enter into assignment of invention agreements with our

employees pursuant to which such individuals assign to us all rights to any inventions created in the scope of their employment or engagement

Although our employees have agreed to assign to our service invention rights, we may face claims demanding remuneration in consideration

for assigned inventions.

As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current

or former employees or be forced to litigate such claims, which could negatively affect our business.

Under the Israeli Patent Law, 5727-1967, or the Patent Law,

inventions conceived by an employee during the term and as part of the scope of his or her employment with a company are regarded as “service

inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the employee service

invention rights.

The Patent Law also provides that, if there is no such agreement between an employer and an employee, the Israeli Compensation

and Royalties Committee, or the Committee, a body constituted under the Patent Law, shall determine whether the employee is entitled to

remuneration for his or her inventions.

We generally enter into assignment of invention agreements with our employees pursuant to which

such individuals assign to us all rights to any inventions created in the scope of their employment or engagement with us.

employees have agreed to assign to our service invention rights, we may face claims demanding remuneration in consideration for assigned

As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current or former

employees or be forced to litigate such claims, which could negatively affect our business.

Risks Related to Our Reliance on Third Parties

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clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such

We continue to rely on third parties, such as

contract research organizations, or CROs, and clinical investigators, to conduct and manage our clinical trials.

We continue to rely on third parties, such as contract

research organizations, or CROs, and clinical investigators, to conduct and manage our clinical trials.

Our reliance on these third parties for research

and development activities will reduce our control over these activities but does not relieve us of our responsibilities.

we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan

and protocols for the trial.

Moreover, the FDA requires us to comply with GCPs for conducting, recording and reporting the results of

clinical trials to assure that data and reported results are credible and accurate and that the rights, safety and welfare of trial participants

we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and

protocols for the trial.

Moreover, the FDA requires us to comply with GCPs for conducting, recording and reporting the results of clinical

trials to assure that data and reported results are credible and accurate and that the rights, safety and welfare of trial participants

are protected.

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Third-party relationships are important to our business.

we are unable to maintain our collaborations or enter into new relationships, or if these relationships are not successful, our business

are unable to maintain our collaborations or enter into new relationships, or if these relationships are not successful, our business

could be adversely affected.

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The relationships we enter into may pose a number 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

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.

● 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

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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.

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,

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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.

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

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 requires 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.

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

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For the years ended

December 31, 2021 and 2020, we recorded grants totaling $3.7 million, $0.5 million, from the IIA, respectively.

December 31, 2022 and 2021, we recorded grants totaling $1.1 million and $3.7 million, from the IIA, respectively.

The grants represented

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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.

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

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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

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.

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As part of funding our current and planned

product development activities, we have submitted follow-up grant applications for new grants.

product development activities, we have submitted follow-up grant applications for additional grants.

These grants have funded some of our personnel,

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However, if these awards are not funded

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

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

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for the reinstatement value of direct damages that are caused by terrorist attacks or acts of war;

however, the government may cease

providing such coverage or the coverage might not be enough to cover potential damages.

In the event that hostilities disrupt the ongoing

operation of our facilities or the airports and seaports on which we depend to import and export our supplies and products, our operations

may be materially adversely affected.

however, the government may cease providing

such coverage or the coverage might not be enough to cover potential damages.

In the event that hostilities disrupt the ongoing operation

of our facilities or the airports and seaports on which we depend to import and export our supplies and products, our operations may be

materially adversely affected.

Several countries, principally in the Middle East,

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based on Israeli government policies.

Such actions, particularly if they become more widespread, may adversely impact our ability to

cooperate with research institutions and collaborate with other third parties.

Any hostilities involving Israel, any interruption or

curtailment of trade or scientific cooperation between Israel and its present partners, or a significant downturn in the economic or

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

We may also be targeted

by cyber terrorists specifically because we are an Israeli-related company.

Such actions, particularly if they become more widespread, may adversely impact our ability to cooperate

with research institutions and collaborate with other third parties.

Any hostilities involving Israel, any interruption or curtailment

of trade or scientific cooperation between Israel and its present partners, or a significant downturn in the economic or financial condition

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

We may also be targeted by cyber terrorists

specifically because we are an Israeli-related company.

Notwithstanding such boycotts and other hostile

actions, in August 2020, an agreement for the normalization of relations between Israel and the United Arab Emirates, or UAE, was reached

and in September 2020 the Abraham Accords Peace Treaty was signed at the White House.

The Accords officially established diplomatic relations

between Israel and the UAE.

This was shortly followed by an agreement for the normalization of ties between Israel and the Kingdom of

Bahrain, which was signed in a Joint Communique between Israel and Bahrain in Manama, Bahrain in November 2020.

In December 2020, Israel

and Morocco established full diplomatic relations.

And in January 2021, Sudan acceded to the Abraham Accords during the visit of then-U.S.

Treasury Secretary Steven Mnuchin to Khartoum.

These agreements have led to other trade and military alliances between Israel and neighboring

Arab countries.

In addition, the Israeli government is currently

pursuing extensive changes to Israel’s judicial system.

This has sparked extensive political debate.

In response to the foregoing

developments, many individuals, organizations and institutions, both within and outside of Israel, have voiced concerns that the proposed

changes may negatively impact the business environment in Israel, including due to reluctance of foreign investors to invest or transact

business in Israel, increased currency fluctuations, downgrades in credit rating, increased interest rates, increased volatility in security

markets, and other changes in macroeconomic conditions.

To the extent that any of these negative developments do occur, they may have

an adverse effect on our business, our results of operations and our ability to hire and preserve our employees and to raise additional

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

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upon to perform annual military reserve duty and, in emergency circumstances, could be called to immediate and unlimited active duty.

Our operations could be disrupted by the absence of a significant number of our employees related to military service or the absence

for extended periods of one or more of our executive officers or other key employees.

Such disruption could materially adversely affect

our business and results of operations.

Our operations could be disrupted by the absence of a significant number of our employees related to military service or the absence for

extended periods of one or more of our executive officers or other key employees.

Such disruption could materially adversely affect our

business and results of operations.

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

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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.

securities laws claims in Israel or serve process on our officers

and directors.

Not all of our directors or officers are residents

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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.

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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.

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 was brought.

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 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

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We opened our

own manufacturing facility at our headquarters in Ness Ziona, Israel in the third quarter of 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.

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

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As of December 31, 2022, we had an aggregate of 13,652,974

13,652,974 warrants outstanding to purchase an aggregate of up to 9,215,475 shares of Common Stock with a weighted average exercise price

of $9.51, certain of which are included in our outstanding units, certain of which were issued in private placements and certain of which

are traded on the NYSE American under the symbol “PHGE.WS,” or the Outstanding Warrants, in each case subject to adjustment.

To the extent such 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.

warrants outstanding to purchase an aggregate of up to 9,215,475 shares of Common Stock with a weighted average exercise price of $9.51,

certain of which are included in our outstanding units, certain of which were issued in private placements and certain of which are traded

on the NYSE American under the symbol “PHGE.WS,” or the Outstanding Warrants, in each case subject to adjustment.

To the extent

such 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, 2022, we had outstanding

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plan to grant additional options and warrants in the future.

The issuance of additional securities 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.

The issuance of additional securities 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.

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,

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Our Common Stock and certain of our warrants currently

trade on the NYSE American and our Common Stock currently trades on the Tel Aviv Stock Exchange.

If our Common Stock or warrants are

subsequently delisted, we could face significant material adverse consequences, including:

limited availability of market quotations for our securities;

liquidity with respect to our securities;

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;

limited amount of news and analyst coverage for the post-transaction company;

decreased ability to issue additional securities or obtain additional financing in the future.

trade on the NYSE American.

If our Common Stock or warrants are subsequently delisted, we could face significant material adverse consequences,

● a limited availability of market

quotations for our securities;

● 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 post-transaction company;

● a decreased ability to issue

additional securities or obtain additional financing in the future.

As a “smaller reporting company” we are permitted

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laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission

Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our

operations or the operations of our collaborators.

In addition, we may obtain health information from third parties (including research

institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance

Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health

of 2009, or HITECH.

Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use or

disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted

Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations

or the operations of our collaborators.

In addition, we may obtain health information from third parties (including research institutions

from which we obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance Portability

and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health of 2009, or

Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use or disclose individually

identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Additional requirements may also be imposed by

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companies of up to the greater of €20 million or 4% of annual worldwide turnover.

Supervisory authorities also have the ability

to restrict our processing activities if those are deemed not to be in compliance with the GDPR (or local declinations);

Supervisory authorities also have the ability to

restrict our processing activities if those are deemed not to be in compliance with the GDPR (or local declinations);

this may significantly

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new internal privacy governance requirements and obligations to allow individuals to exercise their strengthened privacy rights (e.g.,

the right to access, correct and delete their personal data, to withdraw their consent, etc.), and obligations when contracting with

third parties such as service providers, CROs, etc.

In addition, the GDPR includes restrictions on data transfers outside the European

Economic Area, or EEA.

The actual mechanisms made available under GDPR to transfer such personal data have received heightened regulatory

and judicial scrutiny.

If we cannot rely on existing mechanisms for transferring personal data from the EEA, the United Kingdom, or other

jurisdictions, we may be unable to transfer personal data in those regions.

Further, the United Kingdom’s vote in favor of exiting

the European Union, often referred to as “Brexit,” has created uncertainty as to whether or not the United Kingdom data protection

legislation will depart from the GDPR and how data transfers to and from the United Kingdom will be regulated.

the right to access, correct and delete their personal data, to withdraw their consent, etc.), and obligations when contracting with third

parties such as service providers, CROs, etc.

In addition, the GDPR includes restrictions on data transfers outside the European Economic

Area, or EEA.

The actual mechanisms made available under GDPR to transfer such personal data have received heightened regulatory and judicial

If we cannot rely on existing mechanisms for transferring personal data from the EEA, the United Kingdom, or other jurisdictions,

we may be unable to transfer personal data in those regions.

Further, the United Kingdom’s vote in favor of exiting the European

Union, often referred to as “Brexit,” has created uncertainty as to whether or not the United Kingdom data protection legislation

will depart from the GDPR and how data transfers to and from the United Kingdom will be regulated.

Compliance with U.S.

and international data protection

laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and

disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

Such laws and regulations could limit our ability

to use and share personal or other data, thereby increasing our costs and harming our business and financial condition.

Failure to comply

and international data protection laws and regulations could result in claims, government enforcement actions (which could

include civil or criminal penalties), regulatory actions, private litigation and/or adverse publicity and could negatively affect our

operating results and business.

Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as

well as the providers who share this information with us, may contractually limit our ability to use and disclose the information.

that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations,

laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose

data, or in some cases, impact our ability to operate in certain jurisdictions.

Such laws and regulations could limit our ability to use

and share personal or other data, thereby increasing our costs and harming our business and financial condition.

Failure to comply with

and international data protection laws and regulations could result in claims, government enforcement actions (which could include

civil or criminal penalties), regulatory actions, private litigation and/or adverse publicity and could negatively affect our operating

results and business.

Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the

providers who share this information with us, may contractually limit our ability to use and disclose the information.

Claims that we

have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations,

even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity that could harm

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an adverse impact on our reputation and brand.

Our relationships with healthcare providers, physicians and

third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could

expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Our relationships with healthcare providers, physicians and third-party

payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to

criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party

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with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare

laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, or FCA, and

foreign equivalent legislation, which may constrain the business or financial arrangements and relationships through which such companies

sell, market and distribute pharmaceutical products.

In particular, the promotion, sales and marketing of healthcare items and services,

as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks,

laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, or FCA, and foreign

equivalent legislation, which may constrain the business or financial arrangements and relationships through which such companies sell,

market and distribute pharmaceutical products.

In particular, the promotion, sales and marketing of healthcare items and services, as

well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks,

self-dealing and other abusive practices.

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not limited to:

the federal Anti-Kickback Statute, which prohibits,

among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe

or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of

an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made,

in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.

A person or entity can be found

guilty of violating the statute without actual knowledge of the statute or specific intent to violate it.

In addition, a claim including

items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes

The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one

hand and prescribers, purchasers and formulary managers on the other hand.

● the federal Anti-Kickback Statute,

which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any

kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the

referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may

be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.

A person or entity can

be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it.

In addition, a claim

including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for

purposes of the FCA.

The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on

the one hand and prescribers, purchasers and formulary managers on the other hand.

There are a number of statutory exceptions and regulatory

safe harbors protecting some common activities from prosecution;

federal civil and criminal false claims laws, including the FCA, which

prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims

for payment to, or approval by Medicare, Medicaid or other federal healthcare programs, knowingly making, using or causing to be made

or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government,

or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to

“cause” the submission of false or fraudulent claims.

The FCA also permits a private individual acting as a “whistleblower”

to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

HIPAA, which created new federal criminal statutes

that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or

obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under

the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully

falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection

● federal civil and criminal false

claims laws, including the FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to

be presented, false or fraudulent claims for payment to, or approval by Medicare, Medicaid or other federal healthcare programs, knowingly

making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay

or transmit money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing

an obligation to pay money to the federal government.

Manufacturers can be held liable under the FCA even when they do not submit claims

directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

The FCA also permits

a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations

of the FCA and to share in any monetary recovery;

● HIPAA, which created new federal

criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit

program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or

under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and

willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection

with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.

Similar to the federal

Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific

intent to violate it;

the federal Physician Payment Sunshine Act, created under the Patient

Protection and Affordable Care Act and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical

supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions)

to report annually to the United States Department of Health and Human Services information related to payments or other transfers of

value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners

(physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists

and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate

family members;

federal consumer protection and unfair competition

laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

analogous state and foreign laws and regulations, such as state anti-kickback

and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed

by nongovernmental third-party payors, including private insurers, and may be broader in scope than their federal equivalents;

foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare

and state and foreign laws that require drug manufacturers to report information related to payments and other transfers of

value to physicians and other healthcare providers or marketing expenditures;

Similar to the federal Anti-Kickback

Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate

the federal Physician Payment Sunshine Act, created under the Patient Protection and Affordable Care Act and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers, and may be broader in scope than their federal equivalents;

state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers;

and state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

European Union and other foreign provisions.

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companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare

Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by

government authorities, can be time- and resource-consuming and can divert a company’s attention from the business.

Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government

authorities, can be time- and resource-consuming and can divert a company’s attention from the business.

It is not always possible to identify and deter

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Any potential acquisition or strategic partnership may entail numerous risks, including:

increased operating expenses and cash requirements;

the assumption of additional indebtedness or contingent

● increased operating expenses

and cash requirements;

● the assumption of additional

indebtedness or contingent liabilities;

● 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.

● 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 might be adversely affected by security

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sensitive company data, including our intellectual property, financial data and other proprietary business information.

While certain of our operations have business

continuity and disaster recovery plans and other security measures intended to prevent and minimize the impact of IT-related interruptions,

our IT infrastructure and the IT infrastructure of our consultants, contractors and vendors are vulnerable to damage from cyberattacks,

computer viruses, unauthorized access, electrical failures and natural disasters or other catastrophic events.

We could experience failures

in our information systems and computer servers, which could result in an interruption of our normal business operations and require

substantial expenditure of financial and administrative resources to remedy.

System failures, accidents or security breaches can cause

interruptions in our operations and can result in a material disruption of our targeted phage therapies, product candidates and other

business operations.

The loss of data from completed or future studies or clinical trials could result in delays in our research, development

or regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption

or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or

proprietary information, we could incur regulatory investigations and redresses, penalties and liabilities and the development of our

product candidates could be delayed or otherwise adversely affected.

While certain of our operations have business continuity

and disaster recovery plans and other security measures intended to prevent and minimize the impact of IT-related interruptions, our IT

infrastructure and the IT infrastructure of our consultants, contractors and vendors are vulnerable to damage from cyberattacks, computer

viruses, unauthorized access, electrical failures and natural disasters or other catastrophic events.

We could experience failures in

our information systems and computer servers, which could result in an interruption of our normal business operations and require substantial

expenditure of financial and administrative resources to remedy.

System failures, accidents or security breaches can cause interruptions

in our operations and can result in a material disruption of our targeted phage therapies, product candidates and other business operations.

The loss of data from completed or future studies or clinical trials could result in delays in our research, development or regulatory

approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security

breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary

information, we could incur regulatory investigations and redresses, penalties and liabilities and the development of our product candidates

could be delayed or otherwise adversely affected.

Even though we believe we carry commercially reasonable

business interruption and liability insurance, we might suffer losses as a result of business interruptions that exceed the coverage

available under our insurance policies or for which we do not have coverage.

For example, we are not insured against terrorist attacks

or cyberattacks.

Any natural disaster or catastrophic event could have a significant negative impact on our operations and financial

Moreover, any such event could delay the development of our product candidates.

business interruption and liability insurance, we might suffer losses as a result of business interruptions that exceed the coverage available

under our insurance policies or for which we do not have coverage.

For example, we are not insured against terrorist attacks or cyberattacks.

Any natural disaster or catastrophic event could have a significant negative impact on our operations and financial results.

any such event could delay the development of our product candidates.

In the ordinary course of our business, we collect

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We may also experience security breaches that may remain undetected for an extended period.

Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or internal bad

actors, or breached due to employee error, a technical vulnerability, malfeasance or other disruptions.

We have experienced and expect

to continue to experience actual and attempted cyber-attacks of our IT networks, such as through phishing scams and ransomware.

none of these actual or attempted cyber-attacks has had a material adverse impact on our operations or financial condition, we cannot

guarantee that any such incidents will not have such an impact in the future.

Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or internal bad actors,

or breached due to employee error, a technical vulnerability, malfeasance or other disruptions.

We have experienced and expect to continue

to experience actual and attempted cyber-attacks of our IT networks, such as through phishing scams and ransomware.

Although none of these

actual or attempted cyber-attacks has had a material adverse impact on our operations or financial condition, we cannot guarantee that

any such incidents will not have such an impact in the future.

We incur significant costs operating as a public company.

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any net income and may require us to reduce costs in other areas of our business.

of a substantial number of shares of our Common Stock in the public market by our existing stockholders could cause our stock price to

Sales of a substantial number of shares of our Common Stock in

the public market by our existing stockholders could cause our stock price to decline.

Sales of a substantial number of shares of our

Common Stock in the public market or the perception that these sales might occur, could depress the market price of our Common Stock

and could impair our ability to raise capital through the sale of additional equity securities.

We are unable to predict the effect that

sales may have on the prevailing market price of our Common Stock.

Common Stock in the public market or the perception that these sales might occur, could depress the market price of our Common Stock and

could impair our ability to raise capital through the sale of additional equity securities.

For example, if the second part of the PIPE

is completed, we will issue a significant amount of additional new shares of our Common Stock that, once registered for re-sale, will

be freely tradeable.

For example, if the second part of the PIPE is completed, we will issue a significant amount of additional new shares

of our Common Stock that, once registered for re-sale, will be freely tradeable.

We are unable to predict the effect that sales may have

on the prevailing market price of our Common Stock.

The market price of our Common Stock and other securities may

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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:

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

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;

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

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 the 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.

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;

● 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;

● 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 the

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

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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