What changed in this filing

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Item 1A. Risk Factors

2021-03-09 compared with 2020-03-17 · 1124 added, 753 removed, 517 unchanged (78% of the section changed)

You should consider carefully the following

information about the risks described below, together with the other information contained in this Annual Report and in our other

public filings, in evaluating our business.

If any of the following risks actually occurs, our business, financial condition,

results of operations and future growth prospects would likely be materially and adversely affected.

In these circumstances, the

market price of our common stock would likely decline.

Risk Factors Summary

Risks Related to the Proposed Merger with Chemomab

the proposed merger with Chemomab is not consummated, Anchiano could suffer materially

and Anchiano’s share price could decline.

the Merger is not completed, Anchiano’s board of directors may decide to pursue

a dissolution and liquidation of Anchiano.

In such an event, the amount of cash available

for distribution to our shareholders, if any, will depend heavily on the timing of such

liquidation as well as the amount of cash that will need to be reserved for commitments

and contingent liabilities.

shareholders may not realize a benefit from the Merger commensurate with the ownership

dilution they will experience in connection with the Merger.

the Merger be consummated, the combined company may not pursue the advancement of Anchiano’s

existing developmental programs.

Risks Related to Our Business

A pandemic, epidemic or outbreak of an infectious disease

in the United States or elsewhere may adversely affect our business.

If a pandemic, epidemic or outbreak of an infectious disease

occurs in the United States or elsewhere, our business may be adversely affected.

In December 2019, a novel strain of coronavirus,

COVID-19, was identified in Wuhan, China.

This virus continues to spread globally and, as of March 2020, has spread to over 100

countries, including the United States and Israel.

The spread of COVID-19 from China to other countries has resulted in the World

Health Organization declaring the outbreak of COVID-19 as a “pandemic,”

or a worldwide spread of a new disease, on

March 11, 2020.

We are still assessing the effect on our business, from the spread of COVID-19 and the actions implemented by

the governments across the globe.

A significant outbreak of contagious diseases, such as COVID-19, could result in a widespread

health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn.

As a result, our ability to raise additional funds may be adversely impacted by risks, or the public perception of the risks,

related to the recent outbreak of COVID-19.

Furthermore, the third parties we engage, or seek to engage, for preclinical and clinical

development activities may be adversely impacted by risks, or the public perception of the risks, related to the recent outbreak

of COVID-19, which may delay preclinical and clinical development, and increase our costs.

If these third parties do not, or are

unable to, successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them, which

may likewise delay the affected trial preclinical and clinical development.

We are subject to risks and uncertainties arising from

the conclusions that may emerge from our recently initiated strategic review.

On February 26, 2020, our board of directors

determined to advance the preclinical development of our pan-RAS inhibitor program while seeking to identify financing and strategic

opportunities for the company.

The opportunities may include, but are not limited to, a licensing or collaboration agreement involving

the pan-RAS inhibitor program and/or our other in-licensed compound, a potential monetization transaction that may involve the

sale of our rights in the in-licensed compounds or a merger or other strategic transaction.

We cannot assure you that (i) we will

be able to identify financial opportunities to enable our successful development of the pan-RAS inhibitor program;

(ii) the review

of strategic opportunities will result in a proposal for any of the above opportunities;

will be able to identify a suitable merger, collaboration or other strategic partner following the completion of this strategic

or (iv) we will be able to consummate a transaction relating to any of the above opportunities .

We also can provide no assurance that any transaction or other strategic alternative we may pursue will have a positive

impact on our business, financial condition or results of operations.

There is no finite timetable for completion of the strategic

The process of exploring strategic opportunities

will involve the dedication of significant resources and the incurrence of significant costs and expenses.

In addition, speculation

and uncertainty regarding the strategic review process may cause or result in disruption of our business, distraction of our employees,

difficulty in recruiting, hiring, motivating, and retaining talented and skilled personnel, difficulty in maintaining or negotiating

and consummating new business or strategic relationships or transactions (including with ADT), litigation and increased stock price

If we are unable to mitigate these or other potential risks related to the uncertainty caused by the strategic review

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

assessment of strategic opportunities and the evaluation of such assessment to the

extent made by our current board of directors will be subject to review and possible change after our annual general meeting of

shareholders by the then newly composed board of directors.

As a result, you should not place undue reliance on the plans discussed

in the section entitled “Business”

relating to the pan-RAS and PDE10/ß-catenin programs.

We recently changed our business strategy, are now a preclinical

development company, and may encounter difficulties in managing this transition, which could significantly disrupt our business.

On November 15, 2019, we announced the discontinuation

of our Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with bladder cancer.

After analysis

of the data, we determined that there is a low probability of surpassing the predefined futility threshold at the planned interim

analysis, which required 10 complete responses in 35 patients.

The data also indicated a low probability of achieving an efficacy

profile that, in our estimation, would be necessary to support regulatory approval.

As a result, we changed our business strategy

in November 2019 to devote our full resources to our small molecule pan-RAS inhibitor and PDE10/β-catenin inhibitor programs

that we acquired in September 2019.

To manage this change, we have undertaken a workforce reduction in order to accommodate our

new business strategy.

In particular, as previously announced, we are in the process of closing our office and laboratories located

current pandemic of COVID-19 and the future outbreak of other highly infectious or contagious

diseases could seriously affect our business.

will require substantial additional funds to complete our research and development activities,

and, if additional funds are not available, we may need to significantly scale back or

cease our business.

is substantial doubt as to whether we can continue as a going concern.

depend completely on the success of our two preclinical programs and, if we are not able

to advance these successfully through the preclinical and clinical development process,

our business prospects will be materially and adversely affected.

Risks Related to our Preclinical Development

preclinical developmental programs are at an early stage.

As a result, we are unable

to predict if, or when, we will successfully develop or commercialize any product under

either program.

the preclinical and clinical studies that we are required to conduct to gain regulatory

approval are delayed or unsuccessful, we may not be able to market any product that we

develop in the future.

toxicities or serious adverse or undesirable side effects are identified during preclinical

or clinical development, we may need to abandon or limit such development.

Risks Related to our Dependence on Third Parties

are substantially dependent on our Collaboration Agreement with ADT.

If we fail to comply

with our obligations under the Collaboration Agreement into which we entered with ADT,

we could lose development and commercialization rights that are critical to the continuation

of our business if the Merger is not consummated.

expect to rely significantly on preclinical contract research organizations and clinical

research organizations to assist us with the development of the Compounds and any product

that we develop in the future.

we, or if our service providers or any third-party manufacturers, fail to comply with

regulatory requirements, we or they could be subject to enforcement actions, which could

adversely affect our ability to market and sell a product we develop in the future.

Risks Related to our Operations

we are unable to re-hire and retain qualified employees, our ability to implement our

business plan may be adversely affected.

liability claims or lawsuits could cause us to incur substantial liabilities.

disruptions of our information technology systems, or those of our third-party vendors,

or security breaches could adversely affect our business operations and/or result in

the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention

of access to, confidential information, including, among other things, trade secrets

or other intellectual property, proprietary business information and personal information,

and could result in financial, legal, business, and reputational harm to us.

Risks Related to Government Regulation

relationships with customers 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, program exclusion, contractual damages, reputational harm

and diminished profits and future earnings.

and adequate reimbursement may not be available for any future product candidates, which

could make it difficult for us to sell profitably, if approved.

Risks Related to Our Intellectual Property

may be required in the future to license patent rights from third-party owners in order

to develop a product.

If we cannot obtain such licenses, or if such owners do not properly

maintain or enforce the patents underlying such licenses, our competitive position and

business prospects will be harmed.

we are unable to obtain and enforce patent protection for our inventions, our ability

to develop and commercialize any product that we develop in the future will be harmed.

property rights do not necessarily address all potential threats to our competitive advantage.

Risks Related to the ADSs

ADS price could continue to be highly volatile and you may not be able to resell your

ADSs at or above the price you paid for them.

limited number of shareholders will have the ability to influence the outcome of director

elections and other matters requiring shareholder approval.

we no longer qualify as a foreign private issuer, we are required to comply fully with

the reporting requirements of the Exchange Act applicable to U.S.

domestic issuers and,

as a result, are have incurred and will continue to incur significant legal, accounting

and other expenses that we would not incur as a foreign private issuer.

may be subject to limitations on transfer of your ADSs.

Risks Related to the Proposed Merger with Chemomab (the

“Merger”)

If the proposed merger with Chemomab

is not consummated, Anchiano could suffer materially and Anchiano’s share price could decline.

consummation of the proposed Merger with Chemomab is subject to a number of closing conditions, including the approval by our

shareholders, approval by Nasdaq of our initial listing application of our ordinary shares represented by American Depositary

Shares in connection with the Merger, and other customary closing conditions.

In addition, at the closing date of the Merger,

the net cash held by Anchiano, as described in the Merger Agreement, shall be positive or zero, or, if it is negative, the deficit

in such net cash at the closing date of the Merger shall be no greater than $300,000.

We are targeting a closing of the transaction

in March-April 2021.

If the proposed Merger

is not consummated, we may be subject to a number of material risks, and our share price could be adversely affected, as follows:

have incurred and expect to continue to incur significant expenses related to the proposed

Merger with Chemomab, even if the Merger is not consummated.

Merger Agreement contains covenants restricting our solicitation of competing acquisition

proposals and the conduct of our business between the date of signing the Merger Agreement

and the closing of the Merger.

As a result, significant business decisions and transactions

before the closing of the Merger require the consent of Chemomab.

Accordingly, we may

be unable to pursue business opportunities that would otherwise be in our best interest

as a standalone company.

We have invested significant time and resources in the transaction

process and if the Merger Agreement is terminated we will have a limited ability to continue

our current operations without obtaining additional financing.

collaborators and other business partners and investors in general may view the failure

to consummate the Merger as a poor reflection on our business or prospects.

of our collaborators and other business partners may seek to change or terminate their

relationships with us as a result of the proposed Merger or the failure thereof.

a result of the Merger, current and prospective employees could experience uncertainty

about their future roles within the combined company.

This uncertainty may adversely

affect our ability to retain our key employees, who may seek other employment opportunities.

management team may be distracted from day to day operations as a result of the proposed

could determine to delist our ADSs which could have an adverse effect on the value of

our ADSs and any future ability to raise capital.

In addition, if the

Merger Agreement is terminated and our board of directors determines to seek another business combination, it may not be able

to find a third party willing to provide equivalent or more attractive consideration than the consideration to be provided by

each party in the Merger.

In such circumstances, our board of directors may elect to, among other things, divest all or a portion

of our business, or take the steps necessary to liquidate all of our business and assets, and in either such case, the consideration

that we receive may be less attractive than the consideration to be received by us pursuant to the Merger Agreement and related

If the Merger is not completed, Anchiano’s

board of directors may decide to pursue a dissolution and liquidation of Anchiano.

In such an event, the amount of cash available

for distribution to our shareholders, if any, will depend heavily on the timing of such liquidation as well as the amount of cash

that will need to be reserved for commitments and contingent liabilities.

can be no assurance that the Merger will be completed.

If the Merger is not completed, our board of directors may decide to pursue

a dissolution and liquidation of Anchiano.

In such an event, the amount of cash available for distribution to our shareholders

will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution

will be reduced as we continue to fund our operations.

In addition, if our board of directors were to approve and recommend, and

our shareholders were to approve, a dissolution and liquidation, we would be required under Israeli law to pay our outstanding

obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions

in liquidation to our shareholders.

As a result of this requirement, a portion of our remaining cash assets may need to be reserved

pending the resolution of such obligations.

In addition, we may be subject to litigation or other claims related to a dissolution

and liquidation.

If a dissolution and liquidation were pursued, our board of directors, in consultation with its advisors, would

need to evaluate these matters and make a determination about a reasonable amount to reserve.

Accordingly, holders of Anchiano

ADSs could lose all or a significant portion of their investment in the event of Anchiano’s liquidation, dissolution or

Some Anchiano officers and directors

have interests in the Merger that may influence them to support or approve the Merger.

Some of our officers

and directors participate in arrangements that provide them with interests in the Merger that are different from our shareholders,

including, among others, the continued service as an officer or director of the combined company, continued indemnification and

the potential ability to sell an increased number of shares of the combined company in accordance with Rule 144 under the

Securities Act of 1933, as amended.

These interests, among others, may influence our officers and directors to support or approve

The Merger may be completed even though

material adverse changes may result from the announcement of the Merger, industry-wide changes and other causes.

general, either party can refuse to complete the Merger if there is a material adverse change affecting the other party following

December 14, 2020, the date of the Merger Agreement.

However, some types of changes do not permit either party to

refuse to complete the Merger, even if such changes would have a material adverse effect on Anchiano, to the extent they resulted

from the following (unless, in some cases, they have a disproportionate effect on Anchiano or Chemomab, as the case may be):

or conditions generally affecting the industries or markets in which Anchiano and Chemomab

operate, and changes in the industries in which Anchiano and Chemomab operate regardless

of geographic region (including legal and regulatory changes);

of war, armed hostilities or terrorism;

in financial, banking or securities markets;

change in, or any compliance with or action taken for the purpose of complying with,

any federal, state, national, foreign, material local or municipal or other law, statute,

constitution, principle of common law, resolution, ordinance, code, edict, decree, rule,

regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented

or otherwise put into effect by or under the authority of any governmental body (including

under the authority of Nasdaq or the Financial Industry Regulatory Authority), or changes

in any interpretations thereof;

change in U.S.

generally accepted accounting principles or interpretations thereof;

announcement of the Merger Agreement or the pendency of the Merger;

taking of any action required to be taken by the Merger Agreement;

(including the COVID-19 pandemic), including any worsening thereof, man-made disasters,

natural disasters, acts of God or other force majeure event;

general economic or political conditions, or in the financial, credit

or securities markets in general, including any shutdown of any governmental authority.

If adverse changes occur

but Anchiano and Chemomab must still complete the Merger, the combined company’s share price may suffer.

The market price of the combined

company’s shares may decline as a result of the Merger.

The market price

of the combined company’s shares may decline as a result of the Merger for a number of reasons, including if:

combined company does not achieve the perceived benefits of the Merger as rapidly or

to the extent anticipated by financial or industry analysts;

effect of the Merger on the combined company’s business and prospects is not consistent

with the expectations of financial or industry analysts;

react negatively to the effect on the combined company’s business and prospects

from the Merger.

Our shareholders may not realize a

benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

If the combined company

is unable to realize the strategic and financial benefits currently anticipated from the Merger, our shareholders will have experienced

substantial dilution of their ownership interest without receiving any commensurate benefit.

Significant management attention

and resources will be required to integrate the two companies.

Delays in this process could adversely affect the combined company’s

business, financial results, financial condition and share price following the Merger.

Even if the combined company were able

to integrate the business operations successfully, there can be no assurance that this integration will result in the realization

of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that

these benefits will be achieved within a reasonable period of time.

During the pendency of the Merger,

we will be subject to contractual limitations set forth in the Merger Agreement that restrict our ability to enter into business

combination transactions with another party.

in the Merger Agreement impede our ability to make acquisitions or complete other transactions that are not in the ordinary course

of business pending completion of the Merger.

As a result, if the Merger is not completed, we may be at a disadvantage to our

In addition, while the Merger Agreement is in effect and subject to limited exceptions, we are prohibited from soliciting,

initiating, encouraging or taking actions designed to facilitate any inquiries or the making of any proposal or offer that

could lead to entering into certain extraordinary transactions with any third party, such as a sale of assets, an acquisition

of such party’s securities, a tender offer for such party’s securities, a merger or other business combination outside

the ordinary course of business.

Any such transactions could be favorable to our shareholders.

Because the lack of a public market

for Chemomab’s ordinary shares makes it difficult to evaluate the fairness of the Merger, Chemomab’s shareholders

may receive consideration in the Merger that is greater than the fair market value of Chemomab’s ordinary shares.

The outstanding share

capital of Chemomab is privately held and is not traded in any public market.

The lack of a public market makes it difficult to

determine the fair market value of Chemomab’s ordinary shares.

Since the number of Anchiano ADSs to be issued to Chemomab’s

shareholders was determined based on negotiations between the parties, it is possible that the value of the our ADSs to be issued

in connection with the Merger will be greater than the fair market value of Chemomab’s ordinary shares.

The combined company

will incur significant transaction costs as a result of the Merger, including investment banking, legal and accounting fees.

addition, the combined company will incur significant consolidation and integration expenses which cannot be accurately estimated

at this time.

Actual transaction costs may substantially exceed estimates and may have an adverse effect on the combined company’s

financial condition and operating results.

Should the Merger be consummated, Chemomab’s

principal shareholders, and certain executive officers and directors, will own a significant percentage of Anchiano shares and

will be able to exert significant control over matters submitted to the shareholders for approval.

the terms of the Merger Agreement, on a pro-forma basis and after closing of the Merger but prior to the closing of the planned

financing to occur as a condition to the completion of the Merger of at least $30 million , the Chemomab securityholders

immediately before the Merger are expected to own approximately 90% of the aggregate number of ordinary shares of Anchiano (on

a fully diluted basis) and the securityholders of Anchiano immediately before the Merger are expected to own approximately 10%

of the aggregate number of ordinary shares of Anchiano (on a fully diluted basis), subject to certain assumptions and to the net

cash adjustment mechanism set forth in the Merger Agreement.

After the Merger with

Anchiano, certain of Chemomab’s officers and directors, and shareholders who held more than 5% of the Chemomab ordinary

shares, will beneficially own a significant percentage of Anchiano securities.

This significant concentration of share ownership

may adversely affect the trading price for Anchiano securities because investors often perceive disadvantages in owning shares

in companies with controlling shareholders.

These shareholders, if they acted together, could significantly influence all matters

requiring approval by the shareholders following the Merger, including the election of directors and the approval of mergers or

other business combination transactions.

The interests of these shareholders may not always coincide with the interests of other

shareholders.

Certain shareholders could attempt

to influence changes within Anchiano that could adversely affect Anchiano’s operations, financial condition and the value

of Anchiano’s ordinary shares.

Anchiano’s shareholders

may from time to time seek to acquire a controlling stake in Anchiano, engage in proxy solicitations, advance shareholder proposals

or otherwise attempt to effect changes.

Campaigns by shareholders to effect changes at publicly-traded companies are sometimes

led by investors seeking to increase short-term shareholder value through actions such as financial restructuring, increased debt,

special dividends, stock repurchases or sales of assets or the entire company.

Responding to proxy contests and other actions

by activist shareholders can be costly and time-consuming and could disrupt Anchiano’s operations and divert the attention

of the Anchiano board of directors and senior management from the pursuit of the proposed transaction.

These actions could adversely

affect Anchiano’s operations, financial condition, Anchiano’s ability to consummate the Merger and the value of Anchiano

ordinary shares.

Should the Merger be consummated, the

combined company may not pursue the advancement of Anchiano’s existing developmental programs.

September 2019, we entered into an option to license agreement with ADT Pharmaceuticals, LLC pursuant to which the parties

agreed to conduct research and development activities of novel small-molecule inhibitors (RAS and PDE10/β-catenin).

As part of the arrangement, we are primarily responsible for the research, development, manufacturing and regulatory activities

and ADT assists with the research activities as necessary in exchange for a quarterly fee from us.

In connection with the agreement,

ADT also granted us exclusive rights to research, develop, manufacture and commercialize the aforementioned compounds relating

to patents owned by ADT and any products containing such compounds worldwide.

the effective time of the Merger, Chemomab (as successor in interest to Anchiano) will have sole authority over whether and how

to pursue the continued development of the RAS compounds pursuant to the ADT License Agreement (if at all), and there is no guarantee

that Chemomab will pursue the continued development.

Anchiano and Chemomab (as successor in interest to Anchiano following

the Merger) may decide to assign the license agreement or terminate the agreement at any time in its entirety or on a compound-by-compound

basis after providing 90 days written notice to ADT.

Anchiano and Chemomab have become involved

in securities litigation in connection with the Merger and may become involved in additional securities litigation or shareholder

derivative litigation in connection with the Merger, which has and may continue to divert the attention of Anchiano and Chemomab

management and harm the combined company’s business, and insurance coverage may not be sufficient to cover all related costs

Securities litigation

or shareholder derivative litigation frequently follows the announcement of certain significant business transactions, such as

the sale of a business division or announcement of a business combination transaction.

As disclosed in Note 10 of Notes to Consolidated

Financial Statements, Anchiano and Chemomab have been named as defendants in securities litigation in connection with the Merger

and may become involved in additional securities litigation or shareholder derivative litigation in connection with the Merger,

and the combined company may become involved in this type of litigation in the future.

Litigation often is expensive and diverts

management’s attention and resources, which could adversely affect the business of Anchiano, Chemomab and the combined company.

Should the Merger be consummated, following

which Chemomab’s business is expected to constitute a significant portion of the business of the combined company, additional

significant risks may apply to the combined business as detailed in the proxy statement/prospectus previously filed on February 12,

2021, and incorporated by reference herein (File No.

333-252070), and will include “Risks Related to Chemomab’s

Business, Research and Development and the Biopharmaceutical Industry,”

“Risks Related to Chemomab’s Intellectual

Property Rights,”

“Risks Related to Chemomab’s Regulatory Approvals,”

“Risks Related to Commercialization

of Chemomab’s Product Candidates,”

“Risks Related to Chemomab’s Incorporation and Location in Israel,”

or “Risks Related to the Combined Company”

occur, those events could cause the potential benefits of the Merger not

to be realized.

Risks Related to our Business

current pandemic of COVID-19 and the future outbreak of other highly infectious or contagious diseases could seriously

affect our business.

Broad-based business or economic disruptions

could adversely affect our planned research and development activities and ability to raise additional funds.

For example, to

date, the COVID-19 pandemic has caused significant disruptions to the Israeli, United States and global economy and has contributed

to significant volatility and negative pressure in financial markets.

The global impact of the outbreak is continually evolving

and, as additional cases of the virus are identified, many countries, including Israel and the United States, have reacted by

instituting quarantines, restrictions on travel and mandatory closures of businesses.

Most countries, including where we or the

third parties with whom we engage operate, have also reacted by instituting quarantines, restrictions on travel, “shelter

in place”

rules, and restrictions on types of business that may continue to operate.

The extent to which COVID-19 may impact our

activities and operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence,

such as the duration of the outbreak, the severity of COVID-19, or the effectiveness of actions to contain and treat COVID-19.

The continued spread of COVID-19 globally could adversely impact our activities and operations in Israel and the United States,

including our ability to raise additional funds, identify third parties we engage, or seek to engage for preclinical and clinical

development activities, and identify and engage with third parties within the framework of other business and strategic initiatives.

These could all delay progress, increase our operating expenses, and have a material adverse effect on our financial results.

We cannot presently predict the scope and

severity of any potential business shutdowns or disruptions.

If we or any of the third parties with whom we engage, however, were

to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines

presently planned could be materially and negatively affected, which could have a material adverse impact on our business and

our results of operation and financial condition.

We recently changed our business strategy,

are now a preclinical development company, and may encounter difficulties in managing this transition, which could significantly

disrupt our business.

On November 15, 2019, we announced

the discontinuation of our Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with bladder

After analysis of the data, we determined that there is a low probability of surpassing the predefined futility threshold

at the planned interim analysis, which required 10 complete responses in 35 patients.

The data also indicated a low probability

of achieving an efficacy profile that, in our estimation, would be necessary to support regulatory approval.

As a result, we changed

our business strategy in November 2019 to devote our full resources to our small molecule pan-RAS inhibitor and PDE10/β-catenin

inhibitor programs that we acquired in September 2019.

To manage this change, we undertook a workforce reduction in order

to accommodate our new business strategy.

In particular, as previously announced, we closed our office and laboratories located

in Israel due to the discontinuation of our Phase 2 Codex study.

Following the closure of the Israeli facilities, our sole

office will be located in Cambridge, Massachusetts.

Due to our limited resources, we may not be able to effectively manage

this change in our business strategy.

If our current management team is unable to effectively manage this transition, our expenses

may increase more than expected and we may not be able to implement our business strategy.

In addition, as discussed above, our

strategy may be subject to review.

We will require substantial additional funds to complete

our research and development activities, and, if additional funds are not available, we may need to significantly scale back or

cease our business.

office was located in Cambridge, Massachusetts.

Our lease for this office in Cambridge, Massachusetts terminated on February 28,

We are allowed, however, to continue using this address to receive mail.

Due to our limited resources, we may not be able

to effectively manage this change in our business strategy.

If our current management team is unable to effectively manage this

transition, our expenses may increase more than expected and we may not be able to implement our business strategy.

as discussed above, our strategy may be subject to review.

We will require substantial additional

funds to complete our research and development activities, and, if additional funds are not available, we may need to significantly

scale back or cease our business.

We have generated substantial accumulated

10 unchanged sentences

our operations or require us to relinquish rights to our technologies or assets”).

A lack of adequate funding may cause a

cessation of all or part of our research and development activities and business.

A lack of adequate funding may cause

a cessation of all or part of our research and development activities and business.

We will require substantial funds to discover,

1 unchanged sentence

trials, and to manufacture and market any such product that may be approved for commercial sale.

As of December 31, 2019, we held

approximately $17.6 million in cash and cash equivalents.

Our current available funds are not sufficient for all of these activities

and we expect our current available funds to be adequate to satisfy our capital and operating needs through the end of 2020.

financing needs may also increase substantially because of the results of our research and development, preclinical studies and

clinical trials and costs arising from additional regulatory approvals.

We may not succeed in raising additional funds in a timely

The timing of our need for additional funds will depend on a number of factors, which are difficult to predict or may be

outside of our control, including:

the resources, time and costs required to initiate and complete our research and development and to initiate and complete preclinical

studies and clinical trials and to obtain regulatory approvals for any products that we develop in the future;

As of December 31, 2020,

we held approximately $5.4 million in cash and cash equivalents.

Our current available funds are not sufficient for all of these

activities and we expect our current available funds to be adequate to satisfy our capital and operating needs through to the

completion of the contemplated merger.

Our financing needs may also increase substantially because of the results of our research

and development, preclinical studies and clinical trials and costs arising from additional regulatory approvals.

We may not succeed

in raising additional funds in a timely manner.

The timing of our need for additional funds will depend on a number of factors,

which are difficult to predict or may be outside of our control, including:

the resources, time and costs required to initiate

and complete our research and development and to initiate and complete preclinical studies and clinical trials and to obtain

regulatory approvals for any products that we develop in the future;

progress in our research and development programs;

the timing and amount of milestone, royalty and other payments;

costs necessary to protect any intellectual property rights.

our estimates and predictions relating to any of these factors are incorrect, we may need to modify our business plan.

funds may not be available to us when needed on acceptable terms, or at all.

If we are unable to raise funds

on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive

pressures or unanticipated requirements.

the timing and amount of milestone, royalty

and other payments;

costs necessary to protect any intellectual

property rights.

If our estimates and predictions relating

to any of these factors are incorrect, we may need to modify our business plan.

Additional funds may not be available to

us when needed on acceptable terms, or at all.

If we are unable to raise funds on acceptable terms, we may not be able to execute

our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements.

This may seriously harm our business, financial condition and results of operations.

If we are not able to continue operations, investors may suffer a complete loss of their investments in our securities.

We are now an early-stage preclinical biotechnology company

and may never be able to successfully develop a marketable product.

We have only recently acquired two preclinical programs, and

there is no assurance that our future operations will generate any revenue.

If we cannot develop a marketable product or generate

sufficient revenues, we may be required to suspend or cease operations.

If we are not able to continue operations,

investors may suffer a complete loss of their investments in our securities.

We are now an early-stage preclinical

biotechnology company and may never be able to successfully develop a marketable product.

We have only recently acquired two preclinical

programs, and there is no assurance that our future operations will generate any revenue.

If we cannot develop a marketable product

or generate sufficient revenues, we may be required to suspend or cease operations.

We are now an early-stage preclinical biotechnology

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Our operations relating to our two current

preclinical programs have been limited to business planning, performing research, analyzing preclinical data and preparing to advance

identified molecules through additional preclinical studies.

The Compounds identified by us in connection with both our Pan-RAS

and PDE10/ß-catenin programs are in the concept, research and preclinical stages.

As a result, we cannot be certain that

our research and development efforts will be successful or, if successful, that any products that are developed from the Compounds

will ever be approved by the U.S.

Typically, it takes 10 to 12 years to develop one new medicine from the time it is discovered

to when it is available for treating patients, and longer timeframes are not uncommon.

Even if approved, any products that are

developed from the Compounds may not generate sufficient commercial revenues for us to continue operating.

Our operating history

should not be considered when evaluating our performance as it relates to our abandoned bladder cancer product candidate.

result, we are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen

capital requirements, failure of business strategy either in research, preclinical testing or in clinical trials, failure to establish

business relationships, and competitive disadvantages against other companies.

If we fail to become profitable, we may be forced

to suspend or cease our operations.

We do not have a history of commercial sales and do not

anticipate earning operating income over the coming years, and our failure to receive marketing approval for a product that we

develop in the future would negatively impact our ability to continue our business operations.

preclinical programs have been limited to business planning, performing research, analyzing preclinical data and preparing to

advance identified molecules through additional preclinical studies.

The Compounds identified by us in connection with both our

Pan-RAS and PDE10/ß-catenin programs are in the concept, research and preclinical stages.

As a result, we cannot be certain

that our research and development efforts will be successful or, if successful, that any products that are developed from the

Compounds will ever be approved by the U.S.

Typically, it takes 10 to 12 years to develop one new medicine from the time

it is discovered to when it is available for treating patients, and longer timeframes are not uncommon.

Even if approved, any

products that are developed from the Compounds may not generate sufficient commercial revenues for us to continue operating.

operating history should not be considered when evaluating our performance as it relates to our abandoned bladder cancer product

As a result, we are subject to all of the business risks associated with a new enterprise, including, but not limited

to, risks of unforeseen capital requirements, failure of business strategy either in research, preclinical testing or in clinical

trials, failure to establish business relationships, and competitive disadvantages against other companies.

If we fail to become

profitable, we may be forced to suspend or cease our operations.

We do not have a history of commercial

sales and do not anticipate earning operating income over the coming years, and our failure to receive marketing approval for

a product that we develop in the future would negatively impact our ability to continue our business operations.

Our predecessor entity, BioCancell Therapeutics

(“BTI”), was formed on July 26, 2004, and since then we have been a development-stage company.

We have never received

marketing approval for any product candidate and, as a result, have not recorded any sales.

We expect that we will operate at a

loss over the coming years, as we do not expect to generate any revenue from operations in the near term.

We may not be able to

develop, or receive marketing approval for, any product from our current preclinical research and development efforts.

We have never

received marketing approval for any product candidate and, as a result, have not recorded any sales.

We expect that we will operate

at a loss over the coming years, as we do not expect to generate any revenue from operations in the near term.

We may not be able

to develop, or receive marketing approval for, any product from our current preclinical research and development efforts.

even if we obtain all necessary approvals to market a product, there is no certainty that there will be sufficient demand to justify

the production and marketing of any such product.

There is substantial doubt as to whether we can continue

as a going concern.

There is substantial doubt as to whether

we can continue as a going concern.

Our consolidated financial statements as

of December 31, 2019 contain an explanatory paragraph that states that our recurring losses from operations raise substantial doubt

about our ability to continue as a going concern.

Our financial statements do not include any measurement or presentation adjustment

for assets or liabilities that might result if we would be unable to continue as a going concern.

We have incurred operating losses

since inception, have not generated any revenues and have not achieved profitable operations.

Our net loss, accumulated during

the development stage through December 31, 2019, totaled approximately $105.4 million, and we expect to continue to incur substantial

losses in future periods while we continue our research and development activities.

We depend completely on the success of our two preclinical

programs and, if we are not able to advance these successfully through the preclinical and clinical development process, our business

prospects will be materially and adversely affected.

We have no products that are in active clinical

development or approved for commercial sale.

We expect that a substantial portion of our efforts and expenditures over the next

few years will be devoted to the research and development of small molecule inhibitors (pan-RAS and PDE10/β-catenin programs).

Our business depends completely on the successful preclinical and clinical development of products derived from the Compounds.

We cannot be certain that any such product candidate will be developed or receive regulatory approval given that the Compounds

remain in early preclinical stages of development.

of December 31, 2020 contain an explanatory paragraph that states that our recurring losses from operations raise substantial

doubt about our ability to continue as a going concern.

Our financial statements do not include any measurement or presentation

adjustment for assets or liabilities that might result if we would be unable to continue as a going concern.

We have incurred

operating losses since inception, have not generated any revenues and have not achieved profitable operations.

Our net loss, accumulated

during the development stage through December 31, 2020, totaled approximately $117 million, and we expect to continue to

incur substantial losses in future periods while we continue our research and development activities.

We depend completely on the success

of our two preclinical programs and, if we are not able to advance these successfully through the preclinical and clinical development

process, our business prospects will be materially and adversely affected.

We have no products that are in active

clinical development or approved for commercial sale.

We expect that a substantial portion of our efforts and expenditures over

the next few years will be devoted to the research and development of small molecule inhibitors (pan-RAS and PDE10/β-catenin

Our business depends completely on the successful preclinical and clinical development of products derived from the

We cannot be certain that any such product candidate will be developed or receive regulatory approval given that the

Compounds remain in early preclinical stages of development.

Our ability to develop, obtain regulatory

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the following:

successful completion of preclinical studies and clinical trials, which will depend substantially upon the satisfactory performance

of third-party contractors;

successful achievement of the objectives of planned preclinical studies and clinical trials, including the demonstration of

a favorable risk-benefit outcome;

receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States;

establishing efficient and effective commercial manufacturing, supply and distribution arrangements;

establishing sufficient market share and promoting acceptance of the product by patients, the medical community and third-party

successfully executing an effective pricing and reimbursement strategy;

maintaining a continued acceptable safety and adverse event profile following regulatory approval;

qualifying for, identifying, registering, maintaining, enforcing and defending intellectual property rights and claims.

successful completion of preclinical studies

and clinical trials, which will depend substantially upon the satisfactory performance of third-party contractors;

successful achievement of the objectives of

planned preclinical studies and clinical trials, including the demonstration of a favorable risk-benefit outcome;

receipt of marketing approvals from the FDA

and similar regulatory authorities outside the United States;

establishing efficient and effective commercial

manufacturing, supply and distribution arrangements;

establishing sufficient market share and promoting

acceptance of the product by patients, the medical community and third-party payors;

successfully executing an effective pricing

and reimbursement strategy;

maintaining a continued acceptable safety and

adverse event profile following regulatory approval;

qualifying for, identifying, registering, maintaining,

enforcing and defending intellectual property rights and claims.

The Compounds will require additional non-clinical

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If we are unable

to develop or receive marketing approval in a timely manner or at all, we could experience significant delays or an inability to

commercialize products derived from the Compounds, which would materially and adversely affect our business, financial condition

to develop or receive marketing approval in a timely manner or at all, we could experience significant delays or an inability

to commercialize products derived from the Compounds, which would materially and adversely affect our business, financial condition

and results of operations.

Raising additional capital may cause dilution to our existing

shareholders, restrict our operations or require us to relinquish rights to our technologies or assets.

Raising additional capital may cause

dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or assets.

Until such time, if ever, as we can generate

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that adversely affect your rights.

Investors in the June 2018 fundraising are entitled to certain price protection rights with

respect to their ordinary shares and warrants in the event of a future share issue by us where the price per share is less than

the price per share reflected in our initial public offering, which triggered these rights.

Additionally, debt financing, if available,

may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional

debt, making capital expenditures or declaring dividends.

If we are unable to obtain funding on a timely basis, we may be required

to significantly curtail one or both of our preclinical development programs, which would adversely impact our potential revenues,

results of operations and financial condition.

We may allocate our limited resources to pursue a particular

drug candidate or indication and fail to capitalize on drug candidates or indications that may later prove to be more profitable

or for which there is a greater likelihood of success.

Investors in the June 2018 fundraising are entitled to certain price protection rights

with respect to their ordinary shares and warrants in the event of a future share issue by us where the price per share is less

than the price per share reflected in our initial public offering, which triggered these rights.

Additionally, debt financing,

if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such

as incurring additional debt, making capital expenditures or declaring dividends.

If we are unable to obtain funding on a timely

basis, we may be required to significantly curtail one or both of our preclinical development programs, which would adversely

impact our potential revenues, results of operations and financial condition.

We may allocate our limited resources

to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may later prove

to be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial

resources, we must limit our licensing, research, and development programs to specific drug candidates that we identify for specific

As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that

later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on viable

commercial drugs or profitable market opportunities.

In addition, if we do not accurately evaluate the commercial potential or

target market for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration,

As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications

that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on

viable commercial drugs or profitable market opportunities.

In addition, if we do not accurately evaluate the commercial potential

or target market for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration,

licensing, or other royalty arrangements when it would have been more advantageous for us to retain sole development and commercialization

rights to such drug candidate.

The pharmaceutical and biotechnology market is highly

If we are unable to compete effectively with existing products, new treatment methods and new technologies, we may

be unable to commercialize any products that we may develop in the future.

The pharmaceutical and biotechnology

market is highly competitive.

If we are unable to compete effectively with existing products, new treatment methods and new technologies,

we may be unable to commercialize any products that we may develop in the future.

The biotechnology market is highly competitive,

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Many of our competitors have:

much greater experience, financial, technical and human resources than we have at every stage of the discovery, development,

manufacture and commercialization process;

more extensive experience in preclinical studies, conducting clinical trials, obtaining and maintaining regulatory approvals

and manufacturing and marketing products;

products that have been approved or are in late stages of development;

much greater experience, financial, technical

and human resources than we have at every stage of the discovery, development, manufacture and commercialization process;

more extensive experience in preclinical studies,

conducting clinical trials, obtaining and maintaining regulatory approvals and manufacturing and marketing products;

products that have been approved or are in late

stages of development;

established distribution networks;

collaborative arrangements with leading companies and research institutions;

entrenched and established relationships with healthcare providers and payors.

collaborative arrangements with leading companies

and research institutions;

entrenched and established relationships with

healthcare providers and payors.

In addition, many of these companies, in

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position and harm our business prospects.

Even if we receive regulatory approval to market a product

that we develop in the future, the market may not be receptive to the product upon its commercial introduction.

Even if we receive regulatory approval

to market a product that we develop in the future, the market may not be receptive to the product upon its commercial introduction.

We may have difficulties convincing the

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Risks Related to our Preclinical Development

Our preclinical developmental programs are at an early

As a result, we are unable to predict if, or when, we will successfully develop or commercialize any product under either

Our preclinical developmental programs

are at an early stage.

As a result, we are unable to predict if, or when, we will successfully develop or commercialize any product

under either program.

We currently have no products beyond preclinical

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in the future will require significant investment in both preclinical studies and later clinical trials.

We cannot be certain that

preclinical and clinical development of any product derived from our current product development programs will be successful or

that we will obtain regulatory approval or be able to successfully commercialize any product and generate revenue.

Success in preclinical

studies does not ensure that clinical trials will be successful, and the clinical trial process may fail to demonstrate that a

product that we develop is safe and effective for its proposed use.

Any such failure could cause us to abandon further development

of one or more products and may delay development of other potential products.

Any delay in, or termination of, our preclinical

studies or clinical trials will delay and possibly preclude the filing of a new drug application with the FDA or comparable regulatory

authorities and, ultimately, our ability to generate any product revenue.

Any product that we develop in the future will be required

to undergo a time-consuming, costly and burdensome pre-market approval process, and we may be unable to obtain regulatory approval

for such product.

We cannot be certain

that preclinical and clinical development of any product derived from our current product development programs will be successful

or that we will obtain regulatory approval or be able to successfully commercialize any product and generate revenue.

in preclinical studies does not ensure that clinical trials will be successful, and the clinical trial process may fail to demonstrate

that a product that we develop is safe and effective for its proposed use.

Any such failure could cause us to abandon further

development of one or more products and may delay development of other potential products.

Any delay in, or termination of, our

preclinical studies or clinical trials will delay and possibly preclude the filing of a new drug application with the FDA or comparable

regulatory authorities and, ultimately, our ability to generate any product revenue.

Any product that we develop in the

future will be required to undergo a time-consuming, costly and burdensome pre-market approval process, and we may be unable to

obtain regulatory approval for such product.

Any product that we develop in the future

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a lengthy review of our NDA submission.

There can be no assurance that the FDA will

grant a license for any NDA that we may submit.

It is possible that none of the products that we develop in the future will obtain

the appropriate regulatory approvals necessary for us to commence the offer and sale of such products.

Any delay or failure in

obtaining required approvals could have a material adverse effect on our ability to generate revenues from a particular prospective

There can be no assurance that the FDA

will grant a license for any NDA that we may submit.

It is possible that none of the products that we develop in the future will

obtain the appropriate regulatory approvals necessary for us to commence the offer and sale of such products.

Any delay or failure

in obtaining required approvals could have a material adverse effect on our ability to generate revenues from a particular prospective

If we decide to market any drug that we

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process, as well as risks attributable to having to satisfy local regulations within each of these foreign jurisdictions.

Our inability

to obtain regulatory approval outside the United States may adversely compromise our business prospects.

If the preclinical and clinical studies that we are required

to conduct to gain regulatory approval are delayed or unsuccessful, we may not be able to market any product that we develop in

inability to obtain regulatory approval outside the United States may adversely compromise our business prospects.

If the preclinical and clinical studies

that we are required to conduct to gain regulatory approval are delayed or unsuccessful, we may not be able to market any product

that we develop in the future.

We may experience delays in any phase of

the preclinical or clinical development of a product, including during its research and development.

The completion of any of these

studies may be delayed or halted for numerous reasons, including, but not limited to, the following:

the FDA, IRBs, the European Union regulatory authorities (the European Medicines Agency (“EMA”) and national authorities),

or other regulatory authorities do not approve a clinical study protocol or place a clinical study on hold;

patients do not enroll in a clinical study or results from patients are not received at the expected rate;

patients discontinue participation in a clinical study prior to the scheduled endpoint at a higher than expected rate;

patients experience adverse events from a product we develop;

patients die during a clinical study for a variety of reasons that may or may not be related to the product that is the subject

of the study;

third-party clinical investigators do not perform the studies in accordance with the anticipated schedule or consistent with

the study protocol and good clinical practices or other third-party organizations do not perform data collection and analysis in

a timely or accurate manner;

third-party clinical investigators engage in activities that, even if not directly associated with our studies, result in their

debarment, loss of licensure, or other legal or regulatory sanction;

regulatory inspections of manufacturing facilities, which may, among other things, require us to undertake corrective action

or suspend the preclinical or clinical studies;

changes in governmental regulations or administrative actions;

the interim results of the preclinical or clinical study, if any, are inconclusive or negative;

the study design, although approved and completed, is inadequate to demonstrate effectiveness and safety.

We have limited experience in conducting and managing

preclinical studies and any product that we develop in the future may not have favorable results in later clinical trials or receive

regulatory approvals.

have limited experience in conducting and managing the preclinical studies and clinical trials necessary to obtain regulatory

approvals for a product.

We may rely on third parties for preclinical and clinical development activities and our reliance

on third parties will reduce our control over these activities.

Accordingly, third-party contractors may not complete activities

on schedule, or may not conduct preclinical studies and clinical trials in accordance with regulatory requirements or our trial

If these third parties do not successfully carry out their contractual duties or meet expected

deadlines, we may be required to replace them, which may delay the affected trial.

The completion of any of

these studies may be delayed or halted for numerous reasons, including, but not limited to, the following:

the FDA, IRBs, the European Union regulatory

authorities (the European Medicines Agency (“EMA”) and national authorities), or other regulatory authorities

do not approve a clinical study protocol or place a clinical study on hold;

patients do not enroll in a clinical study or

results from patients are not received at the expected rate;

patients discontinue participation in a clinical

study prior to the scheduled endpoint at a higher than expected rate;

patients experience adverse events from a product

patients die during a clinical study for a variety

of reasons that may or may not be related to the product that is the subject of the study;

third-party clinical

investigators do not perform the studies in accordance with the anticipated schedule or consistent with the study protocol

and good clinical practices or other third-party organizations do not perform data collection and analysis in a timely or

accurate manner;

third-party clinical investigators engage in

activities that, even if not directly associated with our studies, result in their debarment, loss of licensure, or other

legal or regulatory sanction;

regulatory inspections of manufacturing facilities,

which may, among other things, require us to undertake corrective action or suspend the preclinical or clinical studies;

changes in governmental regulations or administrative

the interim results of the preclinical or clinical

study, if any, are inconclusive or negative;

the study design, although approved and completed,

is inadequate to demonstrate effectiveness and safety.

have limited experience in conducting and managing preclinical studies and any product that we develop in the future may not have

favorable results in later clinical trials or receive regulatory approvals.

We have limited experience in conducting

and managing the preclinical studies and clinical trials necessary to obtain regulatory approvals for a product.

rely on third parties for preclinical and clinical development activities and our reliance on third parties will reduce our control

over these activities.

Accordingly, third-party contractors may not complete activities on schedule, or may not conduct

preclinical studies and clinical trials in accordance with regulatory requirements or our trial design.

If these third parties

do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them, which may

delay the affected trial.

Clinical failure can occur at any stage

of preclinical or clinical development.

Preclinical studies and clinical trials may produce negative or inconclusive results, and

our collaborators or we may decide, or regulators may require us, to conduct additional clinical trials or nonclinical studies.

Preclinical studies and clinical trials may produce negative or inconclusive results,

and our collaborators or we may decide, or regulators may require us, to conduct additional clinical trials or nonclinical studies.

In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret

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even after seeing promising results in earlier trials or studies.

We may experience difficulties in identifying and recruiting

suitable patients for clinical studies, which may significantly compromise our ability to develop a product in the future.

We may experience difficulties in identifying

and recruiting suitable patients for clinical studies, which may significantly compromise our ability to develop a product in

We may experience difficulties in identifying

and recruiting suitable patients for clinical studies because of the high demand for such patients’

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product, which would adversely impact our potential revenues, results of operations and financial condition.

If toxicities or serious adverse or undesirable side effects

are identified during preclinical or clinical development, we may need to abandon or limit such development.

If toxicities or serious adverse or

undesirable side effects are identified during preclinical or clinical development, we may need to abandon or limit such development.

We do not have a product candidate in clinical

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prevalent, less severe or more acceptable from a risk-benefit perspective.

The commercial value of any clinical study that we may

commence and conduct in the future will significantly depend upon our choice of medical indication and our selection of a patient

population for our clinical study of an indication, and our inability to commence clinical testing or our choice of clinical strategy

The commercial value of any clinical

study that we may commence and conduct in the future will significantly depend upon our choice of medical indication and our selection

of a patient population for our clinical study of an indication, and our inability to commence clinical testing or our choice

of clinical strategy may significantly compromise our business prospects.

If we successfully complete a clinical

study, the commercial value of any such study will depend significantly upon our choice of indication and our selection of a patient

population for that indication.

We may incorrectly assess the market opportunities of an indication or may incorrectly estimate

or fail to appreciate fully the scientific and technological difficulties associated with treating an indication.

the quality and robustness of the results and data of any clinical study that we may conduct in the future will depend upon our

selection of a patient population for clinical testing.

Our inability to commence clinical testing or our choice of clinical strategy

may significantly compromise our business prospects.

If we successfully complete a clinical study,

the commercial value of any such study will depend significantly upon our choice of indication and our selection of a patient population

for that indication.

We may incorrectly assess the market opportunities of an indication or may incorrectly estimate or fail to

appreciate fully the scientific and technological difficulties associated with treating an indication.

Furthermore, the quality

and robustness of the results and data of any clinical study that we may conduct in the future will depend upon our selection of

a patient population for clinical testing.

Our inability to commence clinical testing or our choice of clinical strategy may significantly

compromise our business prospects.

Risks Related to our Dependence on Third Parties

We are substantially dependent on our Collaboration Agreement

If we fail to comply with our obligations under the Collaboration Agreement into which we entered with ADT, we could

lose development and commercialization rights that are critical to the continuation of our business.

On September 20, 2019, we entered into the

Collaboration Agreement with ADT in which we agreed to use commercially reasonable efforts to conduct research and development

Risks Related to our Dependence on Third

We are substantially dependent on our

Collaboration Agreement with ADT.

If we fail to comply with our obligations under the Collaboration Agreement into which we entered

with ADT, we could lose development and commercialization rights that are critical to the continuation of our business if the

Merger is not consummated.

On September 20, 2019, we entered

into the Collaboration Agreement with ADT in which we agreed to use commercially reasonable efforts to conduct research and development

activities with respect to the Compounds under the oversight of a jointly established steering committee.

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to the development and commercialization of any products containing the Compounds.

ADT also granted us an exclusive option to research,

develop, manufacture and commercialize Compounds relating to patents owned by ADT and any products containing such Compounds worldwide

in exchange for an additional fee.

We agreed to pay ADT royalties ranging in the low- to mid-single digit percentage on sales of

any products containing the Compounds.

ADT may terminate the Collaboration Agreement in the event of our material default in any

of our material obligations under the Collaboration Agreement (following a cure period).

In the event the Collaboration Agreement

is terminated, all licenses and options granted to us will be terminated and we will not be able to develop the Compounds or any

products containing the Compounds.

ADT also granted us an exclusive option to

research, develop, manufacture and commercialize Compounds relating to patents owned by ADT and any products containing such Compounds

worldwide in exchange for an additional fee.

We agreed to pay ADT royalties ranging in the low- to mid-single digit percentage

on sales of any products containing the Compounds.

ADT may terminate the Collaboration Agreement in the event of our material

default in any of our material obligations under the Collaboration Agreement (following a cure period).

In the event the Collaboration

Agreement is terminated, all licenses and options granted to us will be terminated and we will not be able to develop the Compounds

or any products containing the Compounds.

The Collaboration Agreement also restricts assignment except to a successor of substantially

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or other transaction.

The loss of such rights would materially adversely affect our business, financial condition, operating results

and prospects.

To the extent the strategic review results in a determination to monetize the pan-RAS program, we may be limited

in our ability to do so.

The failure of ADT to effectively perform its obligations

under the Collaboration Agreement could materially and adversely affect us.

If the Merger is not consummated, the loss of such rights would materially adversely affect our business,

financial condition, operating results and prospects.

To the extent the strategic review results in a determination to monetize

the pan-RAS program, we may be limited in our ability to do so.

The failure of ADT to effectively perform

its obligations under the Collaboration Agreement could materially and adversely affect us.

Pursuant to the terms and conditions set

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containing the Compounds, which would materially adversely affect our business, financial condition, operating results and prospects.

We are dependent on ADT for certain support services related

to our research and development activities with respect to the Compounds and any failure or delay by ADT to provide such services

could harm our business.

We are dependent on ADT for certain

support services related to our research and development activities with respect to the Compounds and any failure or delay by

ADT to provide such services could harm our business.

In connection with the Collaboration Agreement,

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This could impact

our ability to develop the Compounds and materially adversely impact our business, financial condition, operating results and prospects.

We expect to rely significantly on preclinical contract

research organizations and clinical research organizations to assist us with the development of the Compounds and any product that

we develop in the future.

our ability to develop the Compounds and materially adversely impact our business, financial condition, operating results and

We expect to rely significantly on

preclinical contract research organizations and clinical research organizations to assist us with the development of the Compounds

and any product that we develop in the future.

Our reliance on clinical research organizations

may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under

our agreements with them.

In the course of product development, we expect to engage clinical manufacturing organizations to manufacture

drug material for us to be used in non-clinical and clinical testing and contract research organizations to conduct and manage

non-clinical and clinical studies.

As a result, many important aspects of our preclinical research activities and clinical testing

will be out of our direct control.

may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform

under our agreements with them.

In the course of product development, we expect to engage clinical manufacturing organizations

to manufacture drug material for us to be used in non-clinical and clinical testing and contract research organizations to conduct

and manage non-clinical and clinical studies.

As a result, many important aspects of our preclinical research activities and clinical

testing will be out of our direct control.

If any of these organizations we may engage in the future fail to perform their obligations

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our potential drug compounds.

We may seek to enter into further collaborations in the

future, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization

We may seek to enter into further collaborations

in the future, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development

and commercialization plans.

Any collaboration or license agreements

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maintaining insurance coverage;

paying fees related to prosecution, maintenance and enforcement of patent rights;

paying fees related to prosecution, maintenance

and enforcement of patent rights;

minimum annual payments;

undertaking diligent efforts to develop and introduce therapeutic products into the commercial market as soon as practicable.

If we were to breach any of our material

obligations as described above, the counterparties to any such agreements may have the right to terminate the agreement and any

licenses contemplated thereby, which could result in our inability to develop, manufacture and sell products that are covered by

the licensed technology or a competitor gaining access to the licensed technology.

If we, or if our service providers or any third-party

manufacturers, fail to comply with regulatory requirements, we or they could be subject to enforcement actions, which could adversely

affect our ability to market and sell a product we develop in the future.

undertaking diligent efforts to develop and

introduce therapeutic products into the commercial market as soon as practicable.

If we were to breach

any of our material obligations as described above, the counterparties to any such agreements may have the right to terminate

the agreement and any licenses contemplated thereby, which could result in our inability to develop, manufacture and sell products

that are covered by the licensed technology or a competitor gaining access to the licensed technology.

If we, or if our service providers

or any third-party manufacturers, fail to comply with regulatory requirements, we or they could be subject to enforcement actions,

which could adversely affect our ability to market and sell a product we develop in the future.

If we, or if our service providers or any

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restrictions on importation;

suspension of review or refusal to approve new or pending applications;

suspension of review or refusal to approve new

or pending applications;

suspension or withdrawal of product approvals;

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Risks Related to our Operations

If we are unable to retain qualified employees, our ability

to implement our business plan may be adversely affected.

If we are unable to re-hire and retain

qualified employees, our ability to implement our business plan may be adversely affected.

The loss of the service of key employees

Frank Haluska, our Chief Executive Officer, would likely delay our achievement of product development and our other

business objectives.

Although we have employment agreements with our key employees, some of these employment agreements provide

for at-will employment, which means that the employee could terminate his or her employment with us at any time and, for certain

employees, without notice.

We do not carry key man life insurance on any of our executive officers.

during the strategic review process that we went through during 2020 would likely delay our achievement of product development

and our other business objectives should the proposed merger not complete.

Recruiting and retaining qualified scientific,

clinical, manufacturing and sales and marketing personnel will also be critical to our success.

We may not be able to attract and

retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for

similar personnel.

We also experience competition for the hiring of scientific and clinical personnel from universities and research

institutions.

Difficulty in hiring employees to fill key roles could slow or prevent our ability to develop and commercialize our

Our financial condition and the announcement of our process of exploring strategic opportunities may result in difficulties

retaining and attracting qualified employees.

In addition, we work extensively with consultants

and advisors, including scientific and clinical advisors, who provide advice and/or services in various business and development

functions, including preclinical and clinical development, operations and strategy, regulatory matters, legal, and finance, to

assist us in formulating our research and development and commercialization strategy.

The potential success of our drug development

programs depends, in part, on continued collaborations with certain of these consultants and advisors.

Our consultants and advisors

may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities

that may limit their availability to us.

We do not know if we will be able to maintain such relationships or that such consultants

and advisors will not enter into other arrangements with competitors, any of which could have a detrimental impact on our development

objectives and our business.

Under applicable employment laws, we may not be able to

enforce covenants not to compete.

clinical, manufacturing and sales and marketing personnel will be critical to our success.

We may not be able to attract and retain

these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar

We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

Difficulty in hiring employees to fill key roles could slow or prevent our ability to develop and commercialize our products.

Our financial condition and the announcement of our process of exploring strategic opportunities may result in difficulties retaining

and attracting qualified employees.

In addition, we would expect to work extensively

with consultants and advisors, including scientific and clinical advisors, who provide advice and/or services in various business

and development functions, including preclinical and clinical development, operations and strategy, regulatory matters, legal,

and finance, to assist us in formulating our research and development and commercialization strategy.

The potential success of

our drug development programs depends, in part, on collaborations with certain of these consultants and advisors.

Our consultants

and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other

entities that may limit their availability to us.

We do not know if we will be able to build and maintain such relationships or

that such consultants and advisors will not enter into other arrangements with competitors, any of which could have a detrimental

impact on our development objectives and our business.

Under applicable employment laws, we

may not be able to enforce covenants not to compete.

Our employment agreements generally include

covenants not to compete.

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

or working for our competitors for a limited period.

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

us or working for our competitors for a limited period.

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

in which our employees work.

For example, Israeli courts have required employers seeking to enforce covenants not to compete to

demonstrate that the competitive activities of a former employee will harm one of a limited number of material interests of the

employer, such as the secrecy of a company’s confidential commercial information or the protection of its intellectual property.

If we cannot demonstrate that such an interest will be harmed, we may be unable to prevent our competitors from benefiting from

the expertise of our former employees or consultants and our competitiveness may be diminished.

We may be subject to claims that our employees have wrongfully

used or disclosed alleged trade secrets of their former employers.

For example, Israeli courts have required employers seeking to enforce covenants not to compete

to demonstrate that the competitive activities of a former employee will harm one of a limited number of material interests of

the employer, such as the secrecy of a company’s confidential commercial information or the protection of its intellectual

If we cannot demonstrate that such an interest will be harmed, we may be unable to prevent our competitors from benefiting

from the expertise of our former employees or consultants and our competitiveness may be diminished.

We may be subject to claims that our

employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Many of our employees, including our senior

management, were previously employed at other biotechnology or pharmaceutical companies, including our potential competitors.

of these employees may have executed proprietary rights, non-disclosure and non-competition agreements in connection with such

previous employment.

Some of these employees may have executed proprietary rights, non-disclosure and non-competition agreements in connection with

such previous employment.

Although we try to ensure that our employees do not use the proprietary information or know-how of others

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We are not aware of any threatened

or pending claims related to these matters or concerning the agreements with our senior management, but future litigation may be

necessary to defend against such claims.

If we fail in defending any such claims, in addition to paying monetary damages, we may

lose valuable intellectual property rights or personnel.

or pending claims related to these matters or concerning the agreements with our senior management, but future litigation may

be necessary to defend against such claims.

If we fail in defending any such claims, in addition to paying monetary damages, we

may lose valuable intellectual property rights or personnel.

Even if we are successful in defending against such claims, litigation

could result in substantial costs and be a distraction to management.

Our business may be affected by litigation and government

investigations.

Our business may be affected by litigation

and government investigations.

We may from time to time receive inquiries

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While the ultimate outcome of investigations, inquiries, information requests

and legal proceedings is difficult to predict, defense of litigation claims can be expensive, time-consuming and distracting, and

adverse resolutions or settlements of those matters may result in, among other things, modification of our business practices,

and legal proceedings is difficult to predict, defense of litigation claims can be expensive, time-consuming and distracting,

and adverse resolutions or settlements of those matters may result in, among other things, modification of our business practices,

costs and significant payments, any of which could have a material adverse effect on our business, financial condition, results

of operations and prospects.

Product liability claims or lawsuits could cause us to

incur substantial liabilities.

Product liability claims or lawsuits

could cause us to incur substantial liabilities.

We will face an inherent risk of product

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insurance coverage, it may not be adequate to cover all liabilities that we may incur.

Insurance coverage may be increasingly expensive.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may

We are exposed to a risk of substantial loss due to claims

that may be filed against us in the future because our insurance policies may not fully cover the risk of loss associated with

our operations.

Insurance coverage may be increasingly

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability

that may arise.

We are exposed to a risk of substantial

loss due to claims that may be filed against us in the future because our insurance policies may not fully cover the risk of loss

associated with our operations.

We are exposed to the risk of having claims

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and integrity of such confidential information.

We also have outsourced elements of our operations to third parties, and as a result

we manage a number of third-party vendors that may or could have access to our confidential information.

We also have outsourced elements of our operations to third parties, and as a

result we manage a number of third-party vendors that may or could have access to our confidential information.

Attacks on information

technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being conducted

by increasingly sophisticated and organized groups and individuals with a wide range of motives and expertise.

The size and complexity

of our information technology systems, and those of third-party vendors with whom we contract, and the large amounts of confidential

information stored on those systems, make such systems vulnerable to service interruptions or to security breaches from inadvertent

or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious third

Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering

and other means to affect service reliability, and threated the confidentiality, integrity, and availability of information.

technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being

conducted by increasingly sophisticated and organized groups and individuals with a wide range of motives and expertise.

and complexity of our information technology systems, and those of third-party vendors with whom we contract, and the large amounts

of confidential information stored on those systems, make such systems vulnerable to service interruptions or to security breaches

from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks

by malicious third parties.

Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks,

social engineering and other means to affect service reliability, and threated the confidentiality, integrity, and availability

of information.

Significant disruptions of our information

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personal information, and could result in financial, legal, business, and reputational harm to us.

Any failure or perceived failure by us or

any third-party collaborators, service providers, contractors or consultants to comply with our privacy, confidentiality, data

Any failure or perceived failure by us

or any third-party collaborators, service providers, contractors or consultants to comply with our privacy, confidentiality, data

security or similar obligations to third parties, or any data security incidents or other security breaches that result in the

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While we have implemented data security measures intended to protect

our information technology systems and infrastructure, there can be no assurance that such measures will successfully prevent service

interruptions or data security incidents.

our information technology systems and infrastructure, there can be no assurance that such measures will successfully prevent

service interruptions or data security incidents.

Our business and operations would suffer in the event

of system failures.

Despite the implementation of security measures,

our internal computer systems and those of our CROs and other contractors and consultants are vulnerable to damage from computer

viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

While we have not

experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions

in our operations, it could result in a material disruption of our drug development programs.

For example, the loss of preclinical

or clinical data from completed or ongoing or planned preclinical studies or clinical trials could result in delays in our 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 liability and the further development of a product could be delayed.

Despite the implementation of security

measures, our internal computer systems and those of our CROs and other contractors and consultants are vulnerable to damage from

computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause

interruptions in our operations, it could result in a material disruption of our drug development programs.

For example, the loss

of preclinical or clinical data from completed or ongoing or planned preclinical studies or clinical trials could result in delays

in our 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 liability and the further development of a product could be delayed.

Risks Related to Government Regulation

We may be subject to U.S.

federal and state healthcare

fraud and abuse laws and regulations and other regulatory reforms, and a finding of our failure to comply with such laws, regulations

and reforms could have a material adverse effect on our business.

Our operations may be directly or indirectly

affected by various broad U.S.

federal and state healthcare fraud and abuse laws.

These include the U.S.

federal anti-kickback

statute, which prohibits any person from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly

or indirectly, in return for or to induce the referring, ordering, leasing, purchasing or arranging for or recommending the ordering,

purchasing or leasing of an item or service, for which payment may be made under U.S.

federal healthcare programs, such as the

Medicare and Medicaid programs.

federal anti-kickback statute is very broad in scope, and many of its provisions have

not been uniformly or definitively interpreted by existing case law or regulations.

In addition, many states have adopted laws

similar to the U.S.

federal anti-kickback statute, and some of these laws are broader than that statute in that their prohibitions

are not limited to items or services paid for by a U.S.

federal healthcare program but, instead, apply regardless of the source

Violations of these laws could result in fines, imprisonment or exclusion from government-sponsored programs.

Our relationships with customers 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, program exclusion, contractual damages, reputational harm and diminished profits and future

Healthcare providers, physicians and third-party

payors play a primary role in the recommendation of any product for which we obtain marketing approval.

Our future arrangements

with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations

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, program exclusion, contractual damages, reputational harm and diminished profits and future

Healthcare providers, and third-party payors

play a primary role in the recommendation of any product for which we obtain marketing approval.

Our future arrangements with

third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations

that may constrain the business or financial arrangements and relationships through which we market, sell and distribute products

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the following:

the federal healthcare anti-kickback statute, as mentioned above, prohibits, among other things, persons from knowingly and

willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward

either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may

be made under federal and state healthcare programs such as Medicare and Medicaid;

the federal False Claims Act imposes civil penalties, including civil whistleblower actions, against individuals or entities

for knowingly presenting, or causing to be presented, claims for payment to the federal government that are false or fraudulent

or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information

Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare

benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy,

security and transmission of individually identifiable health information;

the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact

or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

the federal transparency requirements under applicable healthcare laws will require manufacturers of drugs, devices, biologics

and medical supplies to report to the Department of Health and Human Services information related to physician payments and other

transfers of value and physician ownership and investment interests;

analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements

and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers,

and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report

information related to payments to physicians and other health care providers or marketing expenditures.

Some state laws require pharmaceutical companies

to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated

by the federal government and may require drug manufacturers to report information related to payments and other transfers of value

to physicians and other healthcare providers or marketing expenditures.

State and foreign laws also govern the privacy and security

of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted

by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our business arrangements

with third parties comply with applicable healthcare laws and regulations will involve substantial costs.

It is possible that governmental

authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving

applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of these

laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative

penalties, damages, fines and exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment

or restructuring of our operations.

If any of the physicians or other providers or entities with whom we expect to do business

are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including

exclusions from government-funded healthcare programs.

the federal healthcare anti-kickback statute,

as mentioned above, prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or

providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual

for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state

healthcare programs such as Medicare and Medicaid;

the federal False Claims Act imposes civil penalties,

including civil whistleblower actions, against individuals or entities for knowingly presenting, or causing to be presented,

claims for payment to the federal government that are false or fraudulent or making a false statement to avoid, decrease or

conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and

Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical

Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also

imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission

of individually identifiable health information;

the federal false statements

statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false

statement in connection with the delivery of or payment for healthcare benefits, items or services;

the federal transparency requirements under

applicable healthcare laws will require manufacturers of drugs, devices, biologics and medical supplies to report to the Department

of Health and Human Services information related to physician payments and other transfers of value and physician ownership

and investment interests;

analogous state laws and regulations, such as

state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items

or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical

companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance

promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments

to physicians and other health care providers or marketing expenditures.

Some state laws require pharmaceutical

companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance

promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures.

State and foreign laws also govern the privacy

and security of health information in some circumstances, many of which differ from each other in significant ways and often are

not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that

our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,

regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found

to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant

civil, criminal and administrative penalties, damages, fines and exclusion from government funded healthcare programs, such as

Medicare and Medicaid, and the curtailment or restructuring of our operations.

If any of the physicians or other providers or

entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal,

civil or administrative sanctions, including exclusions from government-funded healthcare programs.

Coverage and adequate reimbursement may not be available

for any future product candidates, which could make it difficult for us to sell profitably, if approved.

Market acceptance and sales of any product

candidates that we commercialize, if approved, will depend in part on the extent to which coverage and reimbursement for these

drugs and related treatments will be available from third-party payors, including government health administration authorities,

managed care organizations and other private health insurers.

Third-party payors decide which therapies they will pay for and

establish reimbursement levels.

Third-party payors often rely upon Medicare coverage policy and payment limitations in setting

their own coverage and reimbursement policies.

However, decisions regarding the extent of coverage and amount of reimbursement

to be provided for any product candidates that we develop will be made on a payor-by-payor basis.

One third-party payor’s

determination to provide coverage for a drug does not assure that other payors will also provide coverage, and adequate reimbursement,

for the drug.

Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate

reimbursement rate will be approved.

Each third-party payor determines whether or not it will provide coverage for a therapy,

what amount it will pay the manufacturer for the therapy, and on what tier of its formulary it will be placed.

The position on

a third-party payor’s list of covered drugs, or formulary, generally determines the co-payment that a patient will need

to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians.

are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to

reimburse all or part of the associated healthcare costs.

Patients are unlikely to use our products unless coverage is provided

and reimbursement is adequate to cover a significant portion of the cost of our products.

Third-party payors have attempted to

control costs by limiting coverage and the amount of reimbursement for particular medications.

We cannot be sure that coverage

and reimbursement will be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement

Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug for which we obtain marketing

If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able

to successfully commercialize any future product candidates that we may develop.

Healthcare legislative reform measures may have a negative

impact on our business and results of operations.

In the United States and some foreign jurisdictions,

there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare

system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and

affect our ability to profitably sell any product candidates for which we obtain marketing approval.

We expect that healthcare

reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure

on the price that we receive for any approved drug.

Any reduction in reimbursement from Medicare or other government programs

may result in a similar reduction in payments from private third-party payors.

The implementation of cost containment measures

or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize any product

candidate that we may develop.

Inadequate funding for the FDA, the SEC and other government

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The ability of the FDA to review and approve

new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain

key personnel and to accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the

FDA have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies on which

our operations may rely, including those that fund research and development activities is subject to the political process, which

is inherently fluid and unpredictable.

new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and

retain key personnel and to accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times

at the FDA have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies

on which our operations may rely, including those that fund research and development activities is subject to the political process,

which is inherently fluid and unpredictable.

Risks Related to Our Intellectual Property

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products for sale, which could adversely affect our competitive position and harm our business prospects.

Confidentiality agreements with employees and others may

not adequately prevent disclosure of trade secrets and other proprietary information.

Confidentiality agreements with employees and others

may not adequately prevent disclosure of trade secrets and other proprietary information.

We currently rely, and intend to rely in

the future, on trade secrets, know-how and technology that are not protected by patents to maintain our competitive position.

order to protect our proprietary technology and processes, we also rely in part on confidentiality agreements with our collaborators,

In order to protect our proprietary technology and processes, we also rely in part on confidentiality agreements with our collaborators,

employees, consultants, outside scientific collaborators and sponsored researchers and other advisors.

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for our inventions, our ability to develop and commercialize any product that we develop in the future will be harmed.

Our success depends, to a considerable extent,

on our ability to protect proprietary methods and technologies that we develop under the patent and other intellectual property

laws of the United States and other countries, so that we may prevent others from unlawfully using our inventions and proprietary

The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves

complex legal and factual considerations.

Our success depends,

to a considerable extent, on our ability to protect proprietary methods and technologies that we develop under the patent and

other intellectual property laws of the United States and other countries, so that we may prevent others from unlawfully using

our inventions and proprietary information.

The patent position of pharmaceutical or biotechnology companies, including ours,

is generally uncertain and involves complex legal and factual considerations.

The standards that the U.S.

Patent and Trademark Office (the “PTO”) and its

foreign counterparts use to grant patents are not always applied predictably or uniformly and may change.

There also is no uniform,

worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents.

Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of our

intellectual property rights.

Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth

of claims that will be allowed with respect to any patents issued to us or to others.

Additionally, the mere issuance of a patent

does not guarantee that it is valid or enforceable against third parties.

Patent and Trademark

Office (the “PTO”) and its foreign counterparts use to grant patents are not always applied predictably or uniformly

and may change.

There also is no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable

in pharmaceutical or biotechnology patents.

Even if our rights are not directly challenged, disputes among third parties could

lead to the weakening or invalidation of our intellectual property rights.

Accordingly, we do not know the degree of future protection

for our proprietary rights or the breadth of claims that will be allowed with respect to any patents issued to us or to others.

Additionally, the mere issuance of a patent does not guarantee that it is valid or enforceable against third parties.

We may become involved in lawsuits to protect or enforce

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at risk of being invalidated or interpreted narrowly.

Furthermore, because of the substantial amount of discovery required in connection

with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure

during this type of litigation.

In addition, our licensors may have rights to file and prosecute such claims and we are reliant

The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our

favor, could be significant, and the litigation would divert our management’s efforts.

From a financial perspective, there

is a risk that we would not be able to sustain the costs of any such litigation and would be forced to seek bankruptcy or to liquidate

because of our limited asset and revenue base.

Furthermore, because of the substantial amount of discovery required in

connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised

by disclosure during this type of litigation.

In addition, our licensors may have rights to file and prosecute such claims and

we are reliant on them.

The cost to us of any litigation or other proceeding relating to intellectual property rights, even if

resolved in our favor, could be significant, and the litigation would divert our management’s efforts.

From a financial

perspective, there is a risk that we would not be able to sustain the costs of any such litigation and would be forced to seek

bankruptcy or to liquidate because of our limited asset and revenue base.

We may become subject to claims for remuneration or royalties

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and be a distraction to management and other employees.

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.

Although our employees have agreed to assign to us service invention rights and have specifically waived

their right to receive any special remuneration for such assignment beyond their regular salary and benefits, we may face claims

demanding remuneration in consideration for assigned 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.

Although our employees have agreed to assign to us service invention

rights and have specifically waived their right to receive any special remuneration for such assignment beyond their regular salary

and benefits, we may face claims demanding remuneration in consideration for assigned inventions.

Intellectual property rights do not necessarily address

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The following examples are illustrative:

Others may be able to make products that are similar to a product we develop, but that are not covered by the claims of the

patents that we own or have exclusively licensed.

We or our licensors or strategic partners might not have been the first to make the inventions covered by the issued patent

or pending patent application that we own or have exclusively licensed.

We or our licensors or strategic partners might not have been the first to file patent applications covering certain of our

Others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing

our intellectual property rights.

It is possible that our pending patent applications will not lead to issued patents.

Issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held

invalid or unenforceable, as a result of legal challenges by our competitors.

Our competitors might conduct research and development activities in countries where we do not have patent rights and then

use the information learned from such activities to develop competitive products for sale in our major commercial markets.

We may not develop additional proprietary technologies that are patentable.

The patents of others may have an adverse effect on our business.

Should any of these events occur, they could

significantly harm our business, results of operations and prospects.

Others may be able to make products that are

similar to a product we develop, but that are not covered by the claims of the patents that we own or have exclusively licensed.

We or our licensors or strategic partners might

not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have

exclusively licensed.

We or our licensors or strategic partners might

not have been the first to file patent applications covering certain of our inventions.

Others may independently develop similar or

alternative technologies or duplicate any of our technologies without infringing our intellectual property rights.

It is possible that our pending patent applications

will not lead to issued patents.

Issued patents that we own or have exclusively

licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal

challenges by our competitors.

Our competitors might conduct research and development

activities in countries where we do not have patent rights and then use the information learned from such activities to develop

competitive products for sale in our major commercial markets.

We may not develop additional proprietary technologies

that are patentable.

The patents of others may have an adverse effect

on our business.

Should any of these events occur, they

could significantly harm our business, results of operations and prospects.

Risks Related to the ADSs

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you may not be able to resell your ADSs at or above the price you paid for them.

The trading price of the ADSs has been highly

volatile, and is likely to continue to be highly volatile as we undertake the strategic review process, and such volatility may

continue or become more severe if and when a transaction or business arrangement is announced or we announce that we are no longer

exploring strategic opportunities.

From our initial public offering on February 12, 2019 to December 31, 2019, the ADS price has

ranged from $1.04 to $11.50 per ADS.

The following factors, among others, could have a significant impact on the market price of

actual or anticipated fluctuations in our results of operations;

The trading price of the ADSs has been

highly volatile, and is likely to continue to be highly volatile as we undertake the strategic review process, and such volatility

may continue or become more severe if and when a transaction or business arrangement is announced or we announce that we are no

longer exploring strategic opportunities.

From our initial public offering on February 12, 2019 to December 31, 2020,

the ADS price has ranged from $0.54 to $11.50 per ADS.

The following factors, among others, could have a significant impact on

the market price of the ADSs:

actual or anticipated fluctuations in our results

of operations;

changes in operational strategy;

variance in our financial performance from the expectations of market analysts;

announcements by us or our competitors of significant business developments, changes in strategic relationships, acquisitions

or development plans;

announcements by us regarding the clinical development, commercialization and market acceptance of a therapeutic candidate;

variance in our financial performance from the

expectations of market analysts;

announcements by us or our competitors of significant

business developments, changes in strategic relationships, acquisitions or development plans;

announcements by us regarding the clinical development,

commercialization and market acceptance of a therapeutic candidate;

our involvement in litigation;

our sale of ADSs, ordinary shares or other securities in the future;

our sale of ADSs, ordinary shares or other securities

in the future;

changes in personnel;

the trading volume of the ADSs, particularly as a microcap company with a few significant shareholders;

changes in the estimation of the future size and growth rate of our markets;

market conditions in our industry;

general economic and market conditions.

The ADSs may have a low trading volume for

a number of reasons, including that a substantial portion of the ADSs are held by a few significant shareholders, limiting our

public float.

As a result, holders of our ADSs may encounter difficulty selling their ADSs or obtaining a suitable price at which

to sell such ADSs.

the trading volume of

the ADSs, particularly as a microcap company with a few significant shareholders;

changes in the estimation

of the future size and growth rate of our markets;

market conditions in

our industry;

general economic and

market conditions.

The ADSs may have a low trading volume

for a number of reasons, including that a substantial portion of the ADSs are held by a few significant shareholders, limiting

our public float.

As a result, holders of our ADSs may encounter difficulty selling their ADSs or obtaining a suitable price at

which to sell such ADSs.

In addition, the stock markets have experienced

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to influence the outcome of director elections and other matters requiring shareholder approval.

According to a Schedule 13D filed on January

13, 2020, Clal Biotechnology Industries Ltd.

(“CBI”) is the beneficial owner of approximately 23.6% of our outstanding

shares and Access Industries Holdings LLC (“AIH”), Access Industries Management, LLC (“AIM”), Access Industries,

LLC (“LLC”) and Len Blavatnik beneficially own approximately 40.1% of the Company’s outstanding shares (which

includes the shares beneficially owned by CBI).

In addition, according to the Schedule 13G filed on January 2, 2020, the Shavit

Capital Funds collectively beneficially own approximately 21.7% of the Company’s outstanding shares.

to a Schedule 13D filed on December 14, 2020, Clal Biotechnology Industries Ltd., or CBI, is the beneficial owner of approximately

25.1% of our outstanding shares and Access Industries Holdings LLC, or AIH, Access Industries Management, LLC, or AIM,

Access Industries, LLC, or LLC, and Len Blavatnik beneficially own approximately 42.7% of Anchiano’s outstanding shares

(which includes the shares beneficially owned by CBI).

In addition, according to a Schedule 13G filed on January 2, 2020,

the Shavit Capital Funds collectively beneficially own approximately 21.7% of Anchiano’s outstanding shares.

As a result of their significant holdings

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reports about our business or if they issue unfavorable commentary or downgrade the ADSs, the price of the ADSs could decline.

The trading market for the ADSs relies in

part on the research and reports that equity research analysts publish about us and our business.

The price of the ADSs could decline

if one or more securities analysts downgrade the ADSs or if those analysts issue other unfavorable commentary or cease publishing

reports about us or our business.

T he analysts at many brokerage firms do not currently monitor

the trading activity or otherwise provide coverage of lower priced stocks, such as the ADSs.

As a result, many investment funds

are reluctant to invest in lower priced stocks.

Market prices for securities of biotechnology and other life sciences companies

historically have been particularly volatile, subject even to large daily price swings, due in part to the failure to elicit meaningful

stock analyst coverage and downgrades of the company’s stock by analysts.

The trading market for the ADSs relies

in part on the research and reports that equity research analysts publish about us and our business.

The price of the ADSs could

decline if one or more securities analysts downgrade the ADSs or if those analysts issue other unfavorable commentary or cease

publishing reports about us or our business.

The analysts at many brokerage firms do not currently monitor the trading activity

or otherwise provide coverage of lower priced stocks, such as the ADSs.

As a result, many investment funds are reluctant to invest

in lower priced stocks.

Market prices for securities of biotechnology and other life sciences companies historically have been

particularly volatile, subject even to large daily price swings, due in part to the failure to elicit meaningful stock analyst

coverage and downgrades of the company’s stock by analysts.

Because we no longer qualify as a foreign private issuer,

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domestic issuers and, as

a result, are expected to incur significant legal, accounting and other expenses that we would not incur as a foreign private issuer.

Beginning on January 1, 2020, we have been

required to comply fully with the reporting requirements of the Exchange Act applicable to U.S.

domestic issuers because we no

longer qualify as a foreign private issuer.

a result, have incurred and will continue to incur significant legal, accounting and other expenses that we would not incur as

a foreign private issuer.

Beginning on January 1, 2020, we have

been required to comply fully with the reporting requirements of the Exchange Act applicable to U.S.

domestic issuers because

we no longer qualify as a foreign private issuer.

The regulatory and compliance costs to us under U.S.

securities laws as a U.S.

issuer are expected to be significantly higher.

domestic issuer are expected to be significantly higher.

We are now required to file periodic reports, proxy materials and registration

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domestic issuer forms with the SEC, which are more detailed and extensive than the forms available to a foreign

private issuer, and we are required to present our financial statements in accordance with generally accepted accounting principles

in the United States (“U.S.

GAAP”) instead of in accordance with International Financial Reporting Standards (“IFRS”)

as we previously did.

We have also been required to modify certain of our corporate governance policies and committee charters

to comply with accepted governance practices and requirements associated with U.S.

private issuer.We have also been required to modify certain of our corporate governance policies and committee charters to comply

with accepted governance practices and requirements associated with U.S.

domestic listed issuers.

In addition, we lost

our ability to rely upon exemptions from certain Nasdaq corporate governance requirements that are available to foreign private

In addition, we lost our ability

to rely upon exemptions from certain Nasdaq corporate governance requirements that are available to foreign private issuers.

As a result of becoming a public company, our management

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Any future changes in the laws and regulations affecting public companies in the United States,

including Section 404 and other provisions of the Sarbanes-Oxley Act, and the rules and regulations adopted by the SEC and Nasdaq,

for so long as they apply to us, will result in increased costs to us as we respond to such changes.

These laws, rules and regulations

could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability

insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the

same or similar coverage.

The impact of these requirements could also make it more difficult for us to attract and retain qualified

persons to serve on our board of directors, our board committees, if any, or as executive officers.

We do not intend to pay dividends in the foreseeable future.

including Section 404 and other provisions of the Sarbanes-Oxley Act, and the rules and regulations adopted by the SEC

and Nasdaq, for so long as they apply to us, will result in increased costs to us as we respond to such changes.

These laws, rules and

regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer

liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to

obtain the same or similar coverage.

The impact of these requirements could also make it more difficult for us to attract and

retain qualified persons to serve on our board of directors, our board committees, if any, or as executive officers.

We do not intend to pay dividends in the foreseeable

We do not anticipate paying any cash dividends

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as those we make to the holders of our ordinary shares, and, in some limited circumstances, you may not receive dividends or other

distributions on our ordinary shares and you may not receive any value for them, if it is illegal or impractical to make them available

The depositary for the ADSs has agreed to

pay to you the cash dividends or other distributions it or the custodian receives on ordinary shares or other deposited securities

distributions on our ordinary shares and you may not receive any value for them, if it is illegal or impractical to make them

available to you.

The depositary for the ADSs has agreed

to pay to you the cash dividends or other distributions it or the custodian receives on ordinary shares or other deposited securities

underlying the ADSs, after deducting its fees and expenses.

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to make a distribution available to any holders of ADSs.

For example, it would be unlawful to make a distribution to a holder of

ADSs if it consists of securities that require registration under the Securities Act, but that are not properly registered or distributed

under an applicable exemption from registration.

For example, it would be unlawful to make a distribution to a holder

of ADSs if it consists of securities that require registration under the Securities Act, but that are not properly registered

or distributed under an applicable exemption from registration.

In addition, conversion into U.S.

dollars from foreign currency that was part

of a dividend made in respect of deposited ordinary shares may require the approval or license of, or a filing with, any government

or agency thereof, which may be unobtainable.

In these cases, the depositary may determine not to distribute such property and

hold it as “deposited securities”

or may seek to affect a substitute dividend or distribution, including net cash proceeds

from the sale of the dividends that the depositary deems an equitable and practicable substitute.

We have no obligation under U.S.

securities laws to register any ADSs, ordinary shares, rights or other securities received through such distributions.

have no obligation to take any other action to permit the distribution of ADSs, ordinary shares, rights or anything else to holders

In addition, the depositary may deduct from such dividends or distributions its fees and may withhold an amount on account

of taxes or other governmental charges to the extent the depositary believes it is required to make such withholding.

that you may not receive the same distributions or dividends as those we make to the holders of our ordinary shares, and, in some

limited circumstances, you may not receive any value for such distributions or dividends if it is illegal or impractical for us

to make them available to you.

These restrictions may cause a material decline in the value of the ADSs.

ADS holders may not be entitled to a jury trial with respect

to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s) in any such action.

dollars from foreign currency

that was part of a dividend made in respect of deposited ordinary shares may require the approval or license of, or a filing with,

any government or agency thereof, which may be unobtainable.

In these cases, the depositary may determine not to distribute such

property and hold it as “deposited securities”

or may seek to affect a substitute dividend or distribution, including

net cash proceeds from the sale of the dividends that the depositary deems an equitable and practicable substitute.

obligation under U.S.

securities laws to register any ADSs, ordinary shares, rights or other securities received through such

distributions.

We also have no obligation to take any other action to permit the distribution of ADSs, ordinary shares, rights

or anything else to holders of ADSs.

In addition, the depositary may deduct from such dividends or distributions its fees and

may withhold an amount on account of taxes or other governmental charges to the extent the depositary believes it is required

to make such withholding.

This means that you may not receive the same distributions or dividends as those we make to the holders

of our ordinary shares, and, in some limited circumstances, you may not receive any value for such distributions or dividends

if it is illegal or impractical for us to make them available to you.

These restrictions may cause a material decline in the value

ADS holders may not be entitled to a jury trial with

respect to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s) in any

The deposit agreement governing the ADSs

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matters arising under the deposit agreement.

In determining whether to enforce a jury trial waiver provision, New York courts and

federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent

such that a party has knowingly waived any right to trial by jury.

We believe that this is the case with respect to the deposit

agreement and the ADSs.

In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff

or counterclaim sounding in fraud or one that is based upon a creditor’s negligence in failing to liquidate collateral upon

a guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe

are applicable in the case of the deposit agreement or the ADSs.

No condition, stipulation or provision of the deposit agreement

or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision

of the federal securities laws.

If you or any other holder or beneficial owner of ADSs brings a claim against us or the depositary

in connection with matters arising under the deposit agreement or the ADSs, you or such other holder or beneficial owner may not

be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against

us and/or the depositary.

If a lawsuit is brought against us and/or the depositary under the deposit agreement, it may be heard

only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and

may augur different results than a trial by jury would have had, including results that could be less favorable to the plaintiff(s)

in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the

venue of the hearing.

In determining whether to enforce a jury trial waiver provision, New York courts

and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently

prominent such that a party has knowingly waived any right to trial by jury.

We believe that this is the case with respect to

the deposit agreement and the ADSs.

In addition, New York courts will not enforce a jury trial waiver provision in order to bar

a viable setoff or counterclaim sounding in fraud or one that is based upon a creditor’s negligence in failing to liquidate

collateral upon a guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none

of which we believe are applicable in the case of the deposit agreement or the ADSs.

No condition, stipulation or provision of

the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance

with any provision of the federal securities laws.

If you or any other holder or beneficial owner of ADSs brings a claim against

us or the depositary in connection with matters arising under the deposit agreement or the ADSs, you or such other holder or beneficial

owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging

lawsuits against us and/or the depositary.

If a lawsuit is brought against us and/or the depositary under the deposit agreement,

it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil

procedures and may augur different results than a trial by jury would have had, including results that could be less favorable

to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice

hearing such claims, and the venue of the hearing.

Holders of ADSs must act through the depositary to exercise

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We believe that we were a PFIC in 2017, 2018

and 2019 and, based on estimates of our gross income and gross assets and the nature of our business, we believe that we will be

classified as a PFIC for the taxable year ending December 31, 2020.

Because PFIC status is based on our income, assets and activities

for the entire taxable year, it is not possible to determine with certainty whether we will be characterized as a PFIC for the

2020 taxable year until after the close of the year.

Moreover, we must determine our PFIC status annually based on tests that are

factual in nature, and our status in future years will depend on our income, assets and activities in those years.

In any taxable

year in which we are characterized as a PFIC for U.S.

and 2019 and, based on estimates of our gross income and gross assets and the nature of our business, we believe that we will

be classified as a PFIC for the taxable year ending December 31, 2020.

Because PFIC status is based on our income, assets

and activities for the entire taxable year, it is not possible to determine with certainty whether we will be characterized as

a PFIC for the 2020 taxable year until after the close of the year.

Moreover, we must determine our PFIC status annually based

on tests that are factual in nature, and our status in future years will depend on our income, assets and activities in those

In any taxable year in which we are characterized as a PFIC for U.S.

federal income tax purposes, a U.S.

holder that owns ADSs could face adverse

federal income tax consequences, including having gains realized on the sale of the ADSs classified as ordinary income, rather

than as capital gain, the loss of the preferential rate applicable to dividends received on the ADSs by individuals who are U.S.

holder that owns

ADSs could face adverse U.S.

federal income tax consequences, including having gains realized on the sale of the ADSs classified

as ordinary income, rather than as capital gain, the loss of the preferential rate applicable to dividends received on the ADSs

by individuals who are U.S.

holders, and having interest charges apply to distributions by us and the proceeds of ADS sales.

Certain elections exist that may

alleviate some adverse consequences of PFIC status and would result in an alternative treatment (such as mark-to-market treatment)

elections exist that may alleviate some adverse consequences of PFIC status and would result in an alternative treatment (such

as mark-to-market treatment) of the ADSs.

If we are a PFIC in any year, U.S.

holders may be subject to additional Internal Revenue Service (“IRS”)

filing requirements, including the filing of IRS Form 8621, as a result of directly or indirectly owning stock of a PFIC.

holders may be subject to additional Internal Revenue

Service (“IRS”) filing requirements, including the filing of IRS Form 8621, as a result of directly or indirectly

owning stock of a PFIC.

We may be treated as a U.S.

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corporation generally is considered tax resident in the place of its incorporation.

We are incorporated under the laws of the State

of Israel and, therefore, we should be a non-U.S.

We are incorporated under the laws of the

State of Israel and, therefore, we should be a non-U.S.

corporation under this general rule.

However, Section 7874 of the Internal Revenue

Code of 1986, as amended (the “Code”), contains rules that may result in a foreign corporation being treated as a U.S.

However, Section 7874 of the

Internal Revenue Code of 1986, as amended (the “Code”), contains rules that may result in a foreign corporation

being treated as a U.S.

corporation for U.S.

federal income tax purposes.

The application of these rules is complex and there is little guidance regarding

certain aspects of their application.

Under Section 7874 of the Code, a corporation

created or organized outside the United States will be treated as a U.S.

The application of these rules is complex and there

is little guidance regarding certain aspects of their application.

Under Section 7874 of the Code, a

corporation created or organized outside the United States will be treated as a U.S.

corporation for U.S.

federal tax purposes when (i) the

foreign corporation directly or indirectly acquires substantially all of the properties held directly or indirectly by a U.S.

(ii) the former shareholders of the acquired U.S.

corporation hold at least 80% of the vote or value of the shares of the foreign

acquiring corporation by reason of holding stock in the U.S.

acquired corporation, and (iii) the foreign corporation’s “expanded

affiliated group”

federal tax purposes

when (i) the foreign corporation directly or indirectly acquires substantially all of the properties held directly or indirectly

corporation, (ii) the former shareholders of the acquired U.S.

corporation hold at least 80% of the vote or value

of the shares of the foreign acquiring corporation by reason of holding stock in the U.S.

acquired corporation, and (iii) the

foreign corporation’s “expanded affiliated group”

does not have “substantial business activities”

in the foreign corporation’s country

of incorporation relative to its expanded affiliated group’s worldwide activities.

For this purpose, “expanded affiliated

generally means the foreign corporation and all subsidiaries in which the foreign corporation, directly or indirectly,

owns more than 50% of the stock by vote and value, and “substantial business activities”

generally means at least 25%

of employees (by number and compensation), assets and gross income of our expanded affiliated group are based, located and derived,

respectively, in the country of incorporation.

in the foreign corporation’s country of incorporation relative to its expanded affiliated group’s worldwide activities.

For this purpose, “expanded affiliated group”

generally means the foreign corporation and all subsidiaries in which

the foreign corporation, directly or indirectly, owns more than 50% of the stock by vote and value, and “substantial business

activities”

generally means at least 25% of employees (by number and compensation), assets and gross income of our expanded

affiliated group are based, located and derived, respectively, in the country of incorporation.

We were incorporated on September 22,

under the laws of the State of Israel for the purpose of a reincorporation merger (“Reincorporation”), which merged

BTI with and into a wholly-owned subsidiary of BioCancell Ltd.

2011 under the laws of the State of Israel for the purpose of a reincorporation merger (“Reincorporation”), which

merged BTI with and into a wholly-owned subsidiary of BioCancell Ltd.

We do not believe that we should be treated as a U.S.

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However, the IRS may disagree with our conclusion on this point.

In addition, there could be legislative proposals to

expand the scope of U.S.

corporate tax residence and there could be changes to Section 7874 of the Code or the Treasury Regulations

promulgated thereunder that could result in us being treated as a U.S.

In addition, there could be legislative proposals

to expand the scope of U.S.

corporate tax residence and there could be changes to Section 7874 of the Code or the Treasury

Regulations promulgated thereunder that could result in us being treated as a U.S.

If it were determined that we should be

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Failure to achieve and maintain effective internal controls

in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, results of operation

or financial condition.

In addition, current and potential shareholders could lose confidence in our financial reporting, which

could have a material adverse effect on the price of the ADSs.

in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, results of

operation or financial condition.

In addition, current and potential shareholders could lose confidence in our financial reporting,

which could have a material adverse effect on the price of the ADSs.

Effective internal controls are necessary

for us to provide reliable financial reports and effectively prevent fraud.

We are required to document and test our internal control

procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act, which requires annual management assessments

of the effectiveness of our internal controls over financial reporting.

If we fail to maintain the adequacy of our internal controls,

as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on

an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404.

Disclosing deficiencies

or weaknesses in our internal controls, failing to remediate these deficiencies or weaknesses in a timely fashion or failing to

achieve and maintain an effective internal control environment may cause investors to lose confidence in our reported financial

information, which could have a material adverse effect on the price of the ADSs.

If we cannot provide reliable financial reports

or prevent fraud, our operating results could be harmed.

We are required to document and test our internal

control procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act, which requires annual management

assessments of the effectiveness of our internal controls over financial reporting.

If we fail to maintain the adequacy of our

internal controls, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that

we can conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404.

Disclosing deficiencies or weaknesses in our internal controls, failing to remediate these deficiencies or weaknesses in a timely

fashion or failing to achieve and maintain an effective internal control environment may cause investors to lose confidence in

our reported financial information, which could have a material adverse effect on the price of the ADSs.

If we cannot provide

reliable financial reports or prevent fraud, our operating results could be harmed.

As an “emerging growth company”

JOBS Act, we are permitted to, and intend to continue to, rely on exemptions from certain disclosure requirements, which could

make the ADSs less attractive to investors.

Jumpstart Our Business Startups Act, we are permitted to, and intend to continue to, rely on exemptions from certain disclosure

requirements, which could make the ADSs less attractive to investors.

For as long as we are deemed an emerging

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that are generally unavailable to other public companies, including:

an exemption from the auditor attestation requirement in the assessment of our internal controls over financial reporting required

by Section 404 of the Sarbanes-Oxley Act;

an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”)

requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to

provide additional information about our audit and our financial statements.

an exemption from the

auditor attestation requirement in the assessment of our internal controls over financial reporting required by Section 404

of the Sarbanes-Oxley Act;

an exemption from compliance

with any new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”) requiring mandatory

audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional

information about our audit and our financial statements.

We will be an emerging growth company until

the earliest of (i) the last day of the fiscal year during which we had total annual gross revenues of $1.07 billion or more, (ii)

the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt, (iii)

December 31, 2024 or (iv) the date on which we are deemed a “large accelerated issuer”

as defined in Regulation S-K

of the Securities Act.

the earliest of (i) the last day of the fiscal year during which we had total annual gross revenues of $1.07 billion or more,

(ii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt,

(iii) December 31, 2024 or (iv) the date on which we are deemed a “large accelerated issuer”

in Regulation S-K of the Securities Act.

We cannot predict if investors will find

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We could now be treated as a smaller reporting

company given we will report under U.S.

company given that as of January 1, 2020 we are reporting as a U.S.

domestic issuer.

We may take advantage of reduced disclosure and governance

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and therefore qualify as a smaller reporting company under the rules of the SEC.

As a smaller reporting company we are able to

take advantage of reduced disclosure requirements, such as simplified executive compensation disclosures and reduced financial

As a smaller reporting company we are able

to take advantage of reduced disclosure requirements, such as simplified executive compensation disclosures and reduced financial

statement disclosure requirements in its SEC filings.

Decreased disclosures in our SEC filings due to our status as a smaller reporting

company may make it harder for investors to analyze our results of operations and financial prospects.

We cannot predict if investors

will find the ADSs less attractive if we rely on these exemptions.

If some investors find the ADSs less attractive as a result,

there may be a less active trading market for the ADSs and our share price may be more volatile.

We may take advantage of the reporting

exemptions applicable to a smaller reporting company until we are no longer a smaller reporting company, which status would end

once we have a public float greater than $250 million.

In that event, we could still be a smaller reporting company if our

annual revenues were below $100 million and we have a public float of less than $700 million.

Decreased disclosures in our SEC filings due to our status as a smaller

reporting company may make it harder for investors to analyze our results of operations and financial prospects.

We cannot predict

if investors will find the ADSs less attractive if we rely on these exemptions.

If some investors find the ADSs less attractive

as a result, there may be a less active trading market for the ADSs and our share price may be more volatile.

We may take advantage

of the reporting exemptions applicable to a smaller reporting company until we are no longer a smaller reporting company, which

status would end once we have a public float greater than $250 million.

In that event, we could still be a smaller reporting

company if our annual revenues were below $100 million and we have a public float of less than $700 million.

The ADSs may be delisted from Nasdaq if we fail to comply

4 unchanged sentences

specifically enumerated criteria, such as:

a $1.00 minimum closing bid price;

a $1.00 minimum closing

shareholders’

equity of $2.5 million;

500,000 shares of publicly-held shares with a market value of at least $1 million;

500,000 shares of publicly-held

shares with a market value of at least $1 million;

300 round-lot shareholders;

compliance with Nasdaq’s corporate governance requirements, as well as additional or more stringent criteria that may

be applied in the exercise of Nasdaq’s discretionary authority.

There can be no assurance that we will be

able to maintain compliance and remain in compliance in the future.

In particular, our share price may continue to decline for

a number of reasons, including many that are beyond our control.

See “—The ADS price could continue to be highly volatile

and you may not be able to resell your ADSs at or above the price you paid for them.”

compliance with Nasdaq’s

corporate governance requirements, as well as additional or more stringent criteria that may be applied in the exercise of

Nasdaq’s discretionary authority.

There can be no assurance that we will

be able to maintain compliance and remain in compliance in the future.

In particular, our share price may continue to decline

for a number of reasons, including many that are beyond our control.

See “—The ADS price could continue to be highly

volatile and you may not be able to resell your ADSs at or above the price you paid for them.”

If we fail to comply with Nasdaq’s

continued listing standards, we may be delisted and the ADSs will trade, if at all, only on the over-the-counter market, such as

the OTC Bulletin Board or OTCQX market, and then only if one or more registered broker-dealer market makers comply with quotation

continued listing standards, we may be delisted and the ADSs will trade, if at all, only on the over-the-counter market, such

as the OTC Bulletin Board or OTCQX market, and then only if one or more registered broker-dealer market makers comply with quotation

requirements.

In addition, delisting of the ADSs could depress our share price, substantially limit liquidity of the ADSs and materially

adversely affect our ability to raise capital on terms acceptable to us, or at all.

Further, delisting of the ADSs would likely

result in the ADSs becoming a “penny stock”

In addition, delisting of the ADSs could depress our share price, substantially limit liquidity of the ADSs and

materially adversely affect our ability to raise capital on terms acceptable to us, or at all.

Further, delisting of the ADSs

would likely result in the ADSs becoming a “penny stock”

under the Exchange Act.

Recent changes to the composition of our board of directors

may disrupt our business plans.

Three of our directors have recently resigned

from our board of directors.

Additional changes to the composition of our board of directors are likely to occur at our upcoming

annual general meeting of shareholders.

It is possible that these changes in the board’s composition and any future changes

to the composition of our senior management team may disrupt our business and may create uncertainty among investors, employees

and our collaboration partner concerning our future direction and performance.

Any such disruption or uncertainty could have a

material adverse impact on our results of operations and financial condition and the market price of the ADSs.

Unresolved Staff Comments

and senior management may disrupt our business plans.

Four of our directors have recently resigned

from our board of directors and our CEO and CFO were replaced.

It is possible that these changes in the board’s composition

and any future changes to the composition of our senior management team may disrupt our business and may create uncertainty among

investors, employees and our collaboration partner concerning our future direction and performance.

Any such disruption or uncertainty

could have a material adverse impact on our results of operations and financial condition and the market price of the ADSs.

Staff Comments

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