What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2024-08-13 compared with 2023-07-31 · 785 added, 504 removed, 1604 unchanged (45% of the section changed)

27 unchanged sentences

Summary of Risks Associated with Our Business

Our business is subject to numerous risks and uncertainties that you

should consider before investing in our company.

These risks are described in more detail in the section titled “Risk Factors”

in Item 1A of this Report.

Our business is subject to numerous risks and

uncertainties that you should consider before investing in our company.

These risks are described in more detail in the section titled

“Risk Factors” in Item 1A of this Report.

These risks include, but are not limited to, the following:

15 unchanged sentences

We may not be able to protect our intellectual property rights throughout the world.

We rely and expect to continue to rely heavily

on third parties to conduct our preclinical studies, plan to rely on third parties to conduct our and clinical trials, assuming they are

allowed to proceed, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of

such studies and trials.

We rely and expect to continue to rely heavily on third parties to conduct our preclinical studies, plan to rely on third parties to conduct our and clinical trials, assuming they are allowed to proceed, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies and trials.

Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties on which we rely, including Austrianova.

3 unchanged sentences

A large number of shares may be issued and subsequently sold upon the exercise of existing options and warrants and the conversion of preferred shares.

We are a “smaller reporting company” under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

We are a “smaller reporting company” under the Commission’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.

10 unchanged sentences

We have generated significant operating losses since our inception.

Our net losses for the years ended April 30, 2023, and 2022

were approximately $4.3 million and $4.2 million, respectively.

As of April 30, 2023, we had an accumulated deficit of approximately $116

Substantially all our losses have resulted from expenses incurred relating to our research and development programs and from

general and administrative expenses and operating losses associated with our business.

Our net losses attributable to common stockholders for the

years ended April 30, 2024, and 2023 were approximately $17.2 million and $4.3 million, respectively.

As of April 30, 2024, we had an

accumulated deficit of approximately $115.6 million.

Substantially all our losses have resulted from expenses incurred relating to our

research and development programs and from general and administrative expenses and operating losses associated with our business.

We expect to continue to incur significant expenses

39 unchanged sentences

to perform such work for an extended period of time.

Even if we are able to fully respond to the FDA’s requests, they may subsequently

make additional requests that we would need to fulfill prior to the lifting of the clinical hold and we may never be able to begin our

clinical trial in LAPC, obtain regulatory approval or successfully commercialize our product candidates.

An inability to conduct our clinical

trial in LAPC as a result of the clinical hold or otherwise, would likely force us to terminate our clinical development plans.

possible that we will be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may never be lifted.

If the clinical hold is not lifted or if the lifting takes an extended period of time, our business and prospects will likely suffer material

adverse consequences.

Even if we are able to fully respond to the FDA’s requests, the agency may

subsequently make additional requests that we would need to fulfill prior to the lifting of the clinical hold and we may never be able

to begin our clinical trial in LAPC, obtain regulatory approval or successfully commercialize our product candidates.

An inability to

conduct our clinical trial in LAPC as a result of the clinical hold or otherwise, would likely force us to terminate our clinical development

It is possible that we will be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may

never be lifted.

If the clinical hold is not lifted or if the lifting takes an extended period of time, our business and prospects will

likely suffer material adverse consequences.

We contract with Austrianova for the manufacture

3 unchanged sentences

We do not currently own or operate manufacturing

facilities to produce our encapsulated live cell product candidates for cancer, diabetes and malignant ascites.

facilities to produce our encapsulated live cell product candidates for cancer.

We rely on and expect

19 unchanged sentences

or fail to do so on commercially reasonable terms and in a timely manner, we may not be able to successfully produce and market our encapsulated

live cell and ifosfamide product or any other product candidate or may be delayed in doing so.

live cell and ifosfamide product, if approved, or any other product candidate or may be delayed in doing so.

Even if we can establish such arrangements with

32 unchanged sentences

and potential regulatory approval of our product candidates.

If Eurofins, Austrianova or we are unable to purchase these raw materials

after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed

or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

If we are unable to purchase these raw materials after regulatory approval

has been obtained for our product candidates, the commercial launch of our product candidates, if approved, would be delayed or there

would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

Our current and anticipated future dependence

1 unchanged sentence

to commercialize any products that receive marketing approval on a timely and competitive basis.

Disruptions in the global economy and supply chains may have

a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties

on which we rely, including Austrianova.

Disruptions in the global economy

and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial

condition of the third parties on which we rely, including Austrianova.

The disruptions to the global economy in recent

65 unchanged sentences

could harm our operating results.

Due to the significant resources required for the development

of our programs, and depending on our ability to access capital, we must prioritize development of certain product candidates.

expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates

or indications that may be more profitable or for which there is a greater likelihood of success.

Due to the significant resources

required for the development of our programs, and depending on our ability to access capital, we must prioritize development of certain

product candidates.

We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize

on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

We seek to maintain a process of prioritization

1 unchanged sentence

Until such time, if ever, as the FDA lifts its clinical hold on our IND related to our planned clinical trial in LAPC, our

Cell-in-a-Box ® encapsulation technology is validated in our planned clinical trial, and sufficient additional funding is

available, we have halted spending on behalf of our development program with respect to cannabinoids.

Cell-in-a-Box ® encapsulation technology is validated in our planned clinical trial, and sufficient additional funding

is available, we have halted spending on behalf of our development program with respect to cannabinoids.

Due to the significant resources required for

40 unchanged sentences

our product candidates that we may develop, in-license or acquire in the future.

We face substantial competition, which may result in others discovering,

developing or commercializing competing products before or more successfully than we do.

We face substantial competition,

which may result in others discovering, developing or commercializing competing products before or more successfully than we do.

The development and commercialization of new drug

14 unchanged sentences

Specifically, there are numerous companies developing

or marketing therapies for cancer, diabetes and malignant ascites, including many major pharmaceutical and biotechnology companies.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors

also may obtain regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors

establishing a strong market position before we can enter the market.

or marketing therapies for cancer, including many major pharmaceutical and biotechnology companies.

Our commercial opportunity could be

reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe

side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors also may obtain regulatory

approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong

market position before we can enter the market.

Many of the companies against which we are competing

8 unchanged sentences

as in acquiring technologies complementary to, or necessary for, our programs.

Our future revenues are unpredictable which

causes potential fluctuations in operating results.

Our future revenues are unpredictable

which causes potential fluctuations in operating results.

Because of our limited operating history as a

27 unchanged sentences

and (x) the adverse impacts caused by COVID-19.

We may be unable to adequately protect our

information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal

data, damage our reputation, and subject us to significant financial and legal exposure.

We rely on information technology

systems that we or our third-party providers operate to process, transmit and store electronic information in our day-to-day operations.

In connection with our product discovery efforts, we may collect and use a variety of personal data, such as name, mailing address, email

addresses, phone number and clinical trial information.

A successful cyberattack could result in the theft or destruction of intellectual

property, data, or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our

Cyberattacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect.

Cyberattacks could include wrongful conduct by hostile foreign governments, industrial espionage, wire fraud and other forms of cyber

fraud, the deployment of harmful malware, denial-of-service, social engineering fraud or other means to threaten data security, confidentiality,

integrity and availability.

A successful cyberattack could cause serious negative consequences for us, including, without limitation,

the disruption of operations, the misappropriation of confidential business information, including financial information, trade secrets,

financial loss and the disclosure of corporate strategic plans.

Although we devote resources to protect our information systems, we realize

that cyberattacks are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result

in business, legal, financial or reputational harm to us, or would have a material adverse effect on our results of operations and financial

Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’

personal data could result in significant liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended

by HITECH), and international law (e.g., the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct

new studies and potentially disrupt our business.

In addition, the computer

systems of various third parties on which we rely, and other contractors, consultants and law and accounting firms, may sustain damage

from computer viruses, unauthorized access, data breaches, phishing attacks, cybercriminals, natural disasters (including hurricanes and

earthquakes), terrorism, war and telecommunication and electrical failures.

We rely on our third-party providers to implement effective

security measures and identify and correct for any such failures, deficiencies or breaches.

If we or our third-party providers fail to

maintain or protect our information technology systems and data integrity effectively or fail to anticipate, plan for or manage significant

disruptions to our information technology systems, we or our third-party providers could have difficulty preventing, detecting and controlling

such cyber-attacks and any such attacks could result in losses described above as well as disputes with physicians, patients and our partners,

regulatory sanctions or penalties, increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which

could have a material adverse effect on our business, results of operations, financial condition, prospects and cash flows.

by such third parties to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly

adverse consequences for us.

If we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be

exposed to litigation and governmental investigations, which could lead to a potential disruption to our business.

Risks Related to Regulatory Matters

If we are unable to obtain, or if there

are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates

and our ability to generate revenue will be materially impaired.

If we are unable to obtain, or

if there are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our

product candidates and our ability to generate revenue will be materially impaired.

Our product candidates must obtain marketing approval

32 unchanged sentences

to generate revenues will be materially impaired.

If allowed to proceed with our clinical

development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S., and the

If allowed to proceed with our

clinical development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S.,

regulatory agencies may not accept data from trials conducted in such locations.

Although the FDA may accept data from clinical

trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the regulatory agencies outside

For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance

with ethical principles.

The trial population must also adequately represent the population in the country in which the clinical trial

is being conducted.

The data must be applicable to the U.S.

population and medical practice in the U.S.

in ways that the FDA deems clinically

Generally, the patient population for any clinical trial conducted outside of the U.S.

must be representative of the population

for whom we intend to seek approval in the U.S.

The acceptance of data from clinical trials conducted

outside the U.S.

by the FDA may be subject to certain conditions or may not be accepted at all, and other comparable non-U.S.

authorities may have similar restrictions and conditions with respect to clinical trials conducted outside of their respective jurisdictions.

In cases where data from clinical trials conducted wholly outside of the U.S.

are intended to serve as the basis for marketing approval

in the U.S., the FDA will generally not accept such foreign trial data unless (i) the data are determined to be applicable to the U.S.

population and U.S.

medical practice;

(ii) the trials were performed by clinical investigators of recognized competence and pursuant to

GCP regulations;

and (iii) the FDA is able to validate the data through an onsite inspection, if necessary.

Additionally, the FDA’s

clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met.

Many comparable non-U.S.

regulatory authorities have similar approval requirements.

In addition, while these clinical trials are subject

18 unchanged sentences

by lifting its clinical hold on our IND, we have determined that the data contained in previous clinical trial reports using the Cell-in-a-Box ®

and its Associated Technologies are not enough to advance the program to a Phase 3 pivotal trial.

Therefore, we are designing a

clinical trial that, if successful, we believe will provide the information necessary to plan a Phase 3 pivotal trial.

and its Associated Technologies are not sufficient to advance the program to a Phase 3 pivotal trial.

Therefore, we are designing

a clinical trial that, if successful, we believe will provide the information necessary to plan a Phase 3 pivotal trial.

Our determination

3 unchanged sentences

2b clinical trial currently under clinical hold.

If we are unable to obtain, or if there

are delays in obtaining, required approval from the regulatory agencies, we will not be able to commercialize our product candidates and

our ability to generate revenue will be materially impaired.

Our product candidates must obtain marketing approval

from the FDA for commercialization in the U.S.

and from foreign regulatory agencies for commercialization in countries outside the U.S.

The process of obtaining marketing approvals in the countries in which we intend to sell and distribute our product candidates is expensive

and can take several years if approval is obtained at all.

This process can vary substantially based upon a variety of factors, including

the type, complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate will

prevent us from commercializing that product candidate.

To date, we have not received approval to market any of our product candidates

from regulatory agencies in any jurisdiction.

We have no experience in filing and supporting the applications necessary to gain marketing

approvals and expect to rely on third-party contract research organizations to assist us in this process.

Securing marketing approval

requires the submission of extensive preclinical and clinical data and supporting information to the regulatory agencies for each product

candidate to establish the product candidate’s safety and efficacy.

Securing marketing approval also requires the submission of

information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory agencies.

Our product candidates may not be effective, may

be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may

preclude our obtaining marketing approval or prevent or limit commercial use.

Regulatory agencies have substantial discretion in the approval

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

clinical or other studies.

In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay,

limit or prevent marketing approval of a product candidate.

Changes in marketing approval policies during the development period, changes

in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may

also cause delays in or prevent the approval of an application.

New cancer drugs frequently are indicated only for patient populations

that have not responded to an existing therapy or have relapsed after such therapies.

If we experience delays in obtaining approval or

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

to generate revenues will be materially impaired.

Development of a biologic involves a lengthy

16 unchanged sentences

development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of

severe or medically or commercially unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements

medically or commercially unacceptable or severe adverse events, failure to comply with protocols or applicable regulatory requirements

or determination by the regulatory agencies that a drug or biologic product is not approvable.

8 unchanged sentences

when that is not, in fact, the case.

The outcome of preclinical studies and early and

mid-phase clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not

necessarily predict overall results.

Many companies in the pharmaceutical and biotechnology sectors have suffered significant setbacks

in late-stage clinical trials after achieving positive results in earlier stages of development, and we cannot be certain that we will

not face similar setbacks.

The design of a clinical trial can determine whether

10 unchanged sentences

for our product candidates warrant marketing approval, the regulatory agencies may disagree and may not grant marketing approval of our

product candidates or may require that we conduct initial clinical studies;

product candidates or may require that we conduct additional clinical studies;

the latter would require that we incur significantly increased

5 unchanged sentences

Any Phase 1, Phase 2 or Phase 3 clinical trial we

may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidates.

may conduct may not demonstrate the efficacy or safety necessary to obtain regulatory approval to market our product candidates.

Additionally, any positive results of preclinical

studies and early clinical trials of a drug candidate may not be predictive of the results of later-stage clinical trials, such that drug

candidates may reach later stages of clinical trials and fail to show the desired safety and efficacy traits despite having shown indications

of those traits in preclinical studies and early-stage clinical trials.

A number of companies in the biopharmaceutical industry have suffered

significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results

in earlier phases of the trials.

Therefore, the results of any ongoing or future clinical trials we conduct may not be successful.

We may experience significant delays in pursuing

any clinical trials, and any planned clinical trials may not begin on time, may require redesign, may not enroll sufficient healthy volunteers

or patients in a timely manner and may not be completed on schedule, if at all.

Our clinical trials may be delayed, suspended

or prematurely terminated because costs are greater than we anticipate or for a variety of other reasons, such as:

delay or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a trial design that we are able to execute;

delay or failure in obtaining authorization to commence a trial, including approval from the appropriate IRB to conduct testing of a candidate on human subjects, or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;

delay in reaching, or failure to reach, agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

inability, delay or failure in identifying and maintaining a sufficient number of trial sites, many of which may already be engaged in other clinical programs;

delay or failure in recruiting and enrolling suitable volunteers or patients to participate in a trial;

delay or failure in developing and validating companion diagnostics, if they are deemed necessary, on a timely basis;

failure of trial participants to complete a trial or return for post-treatment follow-up;

inability to monitor trial participants adequately during or after treatment;

clinical sites and investigators deviating from trial protocols, failing to conduct the trial in accordance with regulatory requirements or dropping out of a trial;

failure to initiate or delay of or inability to complete a clinical trial as a result of a clinical hold imposed by the FDA or comparable foreign regulatory authority due to observed safety findings or other reasons;

negative or inconclusive results in our clinical trials, and our decision to or regulators’ requirement that we conduct additional non-clinical studies, clinical trials or that we abandon one or more of our product development programs;

inability to manufacture sufficient quantities of a drug candidate of acceptable quality for use in clinical trials.

Further, we may also encounter delays if a clinical

trial is suspended or terminated by us, by any IRB or ethics committee, by a DSMB, or by the FDA or other regulatory authority.

or termination may occur due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements,

inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, exposing participants to health

risks caused by unforeseen safety issues or adverse side effects, development of previously unseen safety issues, failure to demonstrate

a benefit from using a drug candidate or changes in governmental regulations or administrative actions.

We cannot predict with any certainty

the schedule for commencement or completion of any currently ongoing, planned or future clinical trials.

Many of the factors that cause, or lead to, a

delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for our product

If we experience delays in the commencement or

completion of, or suspension or termination of, any clinical trial for our drug candidates, the commercial prospects of the drug candidate

could be harmed, and our ability to generate product revenues from the drug candidate may be delayed or eliminated.

In addition, any delays

in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardize

regulatory approval of our drug candidates and our ability to commence sales and generate revenues.

The occurrence of any of these events

could harm our business, financial condition, results of operations and prospects significantly.

We are seeking FDA approval to commence

22 unchanged sentences

that have been made to the Cell-in-a-Box ® technology since the time of the earlier trials.

We intend to conduct clinical trials for

certain of our product candidates at sites outside of the U.S., and the U.S.

regulatory agencies may not accept data from trials conducted

in such locations.

Although the FDA may accept data from clinical

trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the regulatory agencies outside

For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance

with ethical principles.

The trial population must also adequately represent the population in the country in which the clinical trial

is being conducted.

The data must be applicable to the U.S.

population and medical practice in the U.S.

in ways that the FDA deems clinically

Generally, the patient population for any clinical trial conducted outside of the U.S.

must be representative of the population

for whom we intend to seek approval in the U.S.

In addition, while these clinical trials are subject

to the applicable local laws, the FDA acceptance of the data will be dependent upon its determination that the trials also complied with

all applicable U.S.

laws and regulations.

There can be no assurance that the FDA will accept data from trials conducted outside of the

If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the U.S., it would likely

result in the need for additional trials that would be costly and time-consuming and delay or permanently halt the development of our

product candidate.

In addition, the conduct of clinical trials outside

could have a significant impact on us.

Risks inherent in conducting international clinical trials include:

Foreign regulatory requirements that could restrict or limit our ability to conduct our clinical trials;

Administrative burdens of conducting clinical trials under multiple foreign regulatory schemes;

Foreign exchange fluctuations;

Diminished protection of intellectual property in some countries.

If clinical trials of our product candidates

fail to demonstrate safety and efficacy to the satisfaction of the regulatory agencies, we may incur additional costs or experience delays

in completing or be unable to complete the development and commercialization of these product candidates.

We are not permitted to commercialize, market,

promote or sell any product candidate in the U.S.

without obtaining marketing approval from the FDA.

Comparable regulatory agencies outside

of the U.S., such as the EMA in the European Union, impose similar restrictions.

We may never receive such approvals.

We may be required

to complete additional preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidates in

humans before we will be able to obtain these approvals.

Clinical testing is expensive, difficult to design

and implement, can take many years to complete and is inherently uncertain as to outcome.

We have not previously submitted an NDA, a BLA

or a MAA to regulatory agencies for any of our product candidates.

Any inability to successfully complete preclinical

and clinical development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory

and commercialization milestones and royalties.

In addition, if:

(i) we are required to conduct additional clinical trials or other testing

of our product candidates beyond the trials and testing that we contemplate;

(ii) we are unable to successfully complete our planned clinical

trials of our product candidates or other testing;

(iii) the results of these trials or tests are unfavorable, uncertain or are only modestly

or (iv) there are unacceptable safety concerns associated with our product candidates, we, in addition to incurring additional

Be delayed in obtaining marketing approval for our product candidates;

Not obtain marketing approval at all;

Obtain approval for indications or patient populations that are not as broad as we intended or desired;

Obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including “black-box” warnings;

Be subject to additional post-marketing testing or other requirements;

Be required to remove the product from the market after obtaining marketing approval.

Results in previous clinical trials of our

17 unchanged sentences

for their products by the regulatory agencies.

If we experience any unforeseen events in

the clinical trials of our product candidates, potential marketing approval or commercialization of our product candidates could be delayed

or prevented.

We may experience numerous unforeseen events during

our clinical trials, if allowed to proceed, that could delay or prevent marketing approval of our product candidates, including:

Clinical trials of our product candidates may produce unfavorable or inconclusive results;

We may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs or candidates;

The number of patients required for clinical trials of our product candidates may be larger than we anticipate, patient enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

Our third-party contractors, including those manufacturing our product candidates, components, or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

Regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

We may experience delays in reaching or may fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

Patients who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;

We may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of a product candidate;

Regulatory agencies or IRBs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their respective standards of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the product candidate or findings of undesirable effects caused by a chemically or mechanistically similar drug or drug candidate;

Regulatory agencies may disagree with our clinical trial design or our interpretation of data from preclinical studies and clinical trials;

Regulatory agencies may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter agreements for clinical and commercial supplies;

The supply or quality of raw materials or manufactured product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience interruptions in supply;

The approval policies or regulations of the regulatory agencies may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.

Product development costs for us will increase

if we experience delays in testing or pursuing marketing approvals.

We may also be required to obtain additional funds to complete clinical

trials and prepare for possible commercialization of our product candidates.

We do not know whether any preclinical studies or clinical

trials will begin as planned, will need to be restructured or will be completed on schedule or at all.

Significant preclinical study or

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

or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates

and may harm our business and results of operations.

In addition, many of the factors that cause, or lead to, clinical trial delays may

ultimately lead to the denial of marketing approval of any of our product candidates.

The review processes of regulatory

authorities are lengthy, time consuming, expensive and inherently unpredictable.

If we are unable to obtain approval for our drug candidates

from applicable regulatory authorities, we will not be able to market and sell those drug candidates in those countries or regions and

our business could be substantially harmed.

The research, testing, manufacturing, labeling,

approval, sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDA in the U.S.

and by the respective regulatory agencies in other countries where regulations differ.

We are not permitted to market our product candidates

until we receive the respective approval of an NDA or BLA from the FDA, or in any foreign countries until we receive the requisite

approval from the respective regulatory agencies in such countries.

The time required to obtain approval, if any, by the FDA, EMA, and

comparable foreign authorities is unpredictable, but typically takes many years following the commencement of clinical trials, if approval

is obtained at all, and depends upon numerous factors, including the substantial discretion of the regulatory agencies and the type, complexity

and novelty of the product candidates involved.

Regulatory agencies have substantial discretion in the approval process and may refuse

to accept any application or may decide that our data are insufficient for approval and require additional nonclinical studies or clinical

We have not submitted a marketing application to the FDA, EMA or any similar regulatory agency in any other jurisdiction.

limited experience in planning and conducting the clinical trials required for marketing approvals, and we have and expect to continue

to rely on third-party CROs to assist us in this process.

Obtaining marketing approval requires the submission of extensive nonclinical

and clinical data and supporting information to regulatory agencies for each therapeutic indication to establish the product candidate’s

safety and efficacy.

Securing marketing approval also requires the submission of information about the product manufacturing process,

and in many cases the inspection of manufacturing, processing and packaging facilities by the regulatory agencies.

Our product candidates

may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other

characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use, or there may be deficiencies in

cGMP compliance by us or by our third-party manufacturers that could result in the candidate not being approved.

Moreover, we have not

obtained regulatory approval for any drug candidate in any jurisdiction and it is possible that none of our existing drug candidates or

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

Our drug candidates could fail to receive, or

could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following:

the FDA or comparable foreign regulatory agencies may disagree with the design or implementation of our clinical trials;

we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory agencies that a drug candidate is safe and effective for its proposed indication;

the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval;

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

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

the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a NDA, BLA, or other submission or to obtain regulatory approval in the U.S.

or elsewhere;

upon review of our clinical trial sites and data, the FDA or comparable foreign regulatory agency may find our record keeping or the record keeping of our clinical trial sites to be inadequate;

the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies may fail to meet the requirements of the FDA or comparable foreign regulatory agencies;

the FDA or comparable foreign regulatory agencies may fail to approve the companion diagnostics we contemplate developing internally or with partners;

the change of the medical standard of care or the approval policies or regulations of the FDA or comparable foreign regulatory agencies may significantly change in a manner that renders our clinical data insufficient for approval.

The time and expense of the approval process,

as well as the unpredictability of future clinical trial results and other contributing factors, may result in our failure to obtain regulatory

approval to market, in one or more jurisdictions, for the product candidates we are currently developing or may seek to develop in the

future, which would significantly harm our business, results of operations and prospects.

In such case, we may also not have the resources

to conduct new clinical trials and/or we may determine that further clinical development of any such drug candidate is not justified and

may discontinue any such programs.

In addition, even if we were to obtain regulatory

approval in one or more jurisdictions, regulatory agencies may approve any of our product candidates for fewer or more limited indications

than we request, may not approve prices we may propose to charge for our products, may grant approval contingent on the performance of

costly post-marketing clinical trials (referred to as “conditional” or “accelerated” approval depending on the

jurisdiction), or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the

successful commercialization of that product candidate or that includes significant warnings or contraindications.

Any of the foregoing

circumstances could materially harm the commercial prospects for our product candidates.

If we experience delays or difficulties

3 unchanged sentences

trials for our product candidates if we are unable to locate and enroll enough eligible patients to participate in our clinical trials.

Patient enrollment is a significant factor in the overall duration of a clinical trial and is affected by many factors, including:

In particular, for some diseases and conditions we are or will be focusing on, our pool of suitable patients may be smaller and more selective

and our ability to enroll a sufficient number of suitable patients may be limited or take longer than anticipated.

In addition, some of

our competitors may have ongoing clinical trials for drug candidates that treat the same indications as our drug candidates, and volunteers

or patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ drug

Patient enrollment is a significant factor in

the overall duration of a clinical trial and is affected by many factors, including:

The size and nature of the patient population;

2 unchanged sentences

The eligibility criteria for the trial;

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

The design of the clinical trial;

Efforts to facilitate timely enrollment;

The patient referral practices of physicians;

Competing clinical trials for the same patient population;

7 unchanged sentences

Enrollment delays may also delay or jeopardize our

ability to commence sales and generate revenues from our product candidates.

Any of the foregoing could cause the value of our company

to decline and limit our ability to obtain additional financing, if needed.

ability to commence sales and generate revenues from our product candidates., if approved Any of the foregoing could cause the value of

our company to decline and limit our ability to obtain additional financing, if needed.

We may request priority review for our product

candidates in the future.

The regulatory agencies may not grant priority review for any of our product candidates.

Moreover, even if the

regulatory agencies designated such products for priority review, that designation may not lead to a faster regulatory review or approval

process and, in any event, does not assure approval by the regulatory agencies.

FDA may not grant priority review for any of our product candidates.

Moreover, even if FDA designated such products

for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, does not assure

regulatory approval of the product.

We may be eligible for priority review designation

for our product candidates if the regulatory agencies determine such product candidates offer major advances in treatment or provide a

treatment where no adequate therapy exists.

A priority review designation means that the time required for the regulatory agencies to

review an application is less than the standard review period.

The regulatory agencies have broad discretion with respect to whether to

grant priority review status to a product candidate, so even if we believe a product candidate is eligible for such designation or status,

the regulatory agencies may decide not to grant it.

Thus, while the regulatory agencies have granted priority review to other oncology

and diabetes products, our product candidates, should we determine to seek priority review of them, may not receive similar designation.

Moreover, even if one of our product candidates is designated for priority review, such a designation does not necessarily mean a faster

overall regulatory review process or necessarily confer any advantage with respect to approval compared to conventional procedures of

the regulatory agencies.

for our product candidates if the regulatory agencies determine such product candidates offer major advances in treatment of a serious

disease or condition or provide a treatment for a serious disease or condition where no adequate therapy exists.

For a description of

priority review designation, see “Government Regulation – Fast Track, Breakthrough Therapy and Priority Review Designations.”

FDA has broad discretion with respect to whether

to grant priority review status to a product candidate, so even if we believe a product candidate is eligible for such designation or

status, FDA may decide not to grant it.

Thus, while FDA has granted priority review to other oncology products, our product candidates,

should we request priority review designation for them, may not receive such designation.

Moreover, even if one of our product candidates

is designated for priority review, such a designation does not change the standards for product approval and does not necessarily mean

a faster overall regulatory review process or necessarily confer any advantage with respect to approval compared to the standard FDA review

Receiving priority review from the regulatory

1 unchanged sentence

In some instances, we believe we may be

able to secure approval from the regulatory agencies to use accelerated development pathways.

If we are unable to obtain such approval,

we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate which could increase

the expense of obtaining and delay the receipt of necessary marketing approvals.

able to secure approval from FDA to use accelerated development pathways.

If we are unable to obtain such approval, we may be required

to conduct additional preclinical studies or clinical trials beyond those that we contemplate which could increase the expense of obtaining

and delay the receipt of necessary marketing approvals.

We anticipate that we may seek an accelerated

approval pathway for certain of our product candidates.

Under the accelerated approval provisions or their implementing regulations of

the regulatory agencies, they may grant accelerated approval to a product designed to treat a serious or life-threatening condition that

provides meaningful therapeutic benefit over available therapies upon a determination that the product influences a surrogate endpoint

or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.

Regulatory agencies consider a clinical benefit

to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic

image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit.

intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality

that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval

pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but

is a clinically important improvement from a patient and public health perspective.

If granted, accelerated approval is usually contingent

on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe

the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s clinical benefit, regulatory agencies

may withdraw their approval of the drug.

Prior to seeking such accelerated approval, we

will seek feedback from the regulatory agencies and will otherwise evaluate our ability to seek and receive such accelerated approval.

There can also be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA,

a BLA or an MAA for accelerated approval or any other form of expedited development, review or approval.

Similarly, there can be no assurance

that after subsequent feedback from regulatory agencies that we will continue to pursue or apply for accelerated approval or any other

form of expedited development, review or approval, even if we initially decide to do so.

For a description of the accelerated approval pathway, see “Government Regulation

– Accelerated Approval Pathway.”

Prior to requesting accelerated approval, we will

seek feedback from the FDA and will otherwise evaluate our eligibility to use the accelerated approval pathway.

There can also be no assurance

that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA or a BLA, as applicable, for accelerated

approval or any other form of designation or program intended to expedite the product development, review or approval processes.

there can be no assurance that after subsequent feedback from the FDA that we will continue to pursue or apply for accelerated approval

or any other form of designation or expedited program, even if we initially decide to do so.

Furthermore, if we decide to apply for accelerated

2 unchanged sentences

granted on a timely basis or at all.

Regulatory agencies could also require us to conduct further studies prior to considering our application

or granting approval of any type.

A failure to obtain accelerated approval or any other form of expedited development, review or approval

for any of our product candidates that we determine to seek accelerated approval for would result in a longer time to commercialization

of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in

the marketplace.

We may seek Orphan Drug designation for

some of our product candidates, and we may be unsuccessful.

Regulatory agencies may designate drugs for relatively

The FDA could also require us to conduct further studies prior to considering or grantingour application

or granting approval of any type and may require us to have a confirmatory trial to verify the clinical benefit of the product underway

and partially or fully enrolled before granting approval.

We might not be able to fulfill the FDA’s requirements in a timely manner,

which would cause delays, or approval might not be granted because our submission is deemed incomplete by the FDA.

Even if we receive accelerated approval from the

FDA, we will be subject to rigorous post-marketing requirements, including the completion of confirmatory post-market clinical trials,

submission to the FDA of periodic progress reports on confirmatory trials, and submission to the FDA of all promotional materials prior

to their dissemination.

The FDA could seek to withdraw any product approval granted through the accelerated approval pathway for multiple

reasons, including if we fail to conduct any required post-market study with due diligence;

a post-market study does not confirm the predicted

clinical benefit;

other evidence shows that the product is not safe or effective under the conditions of use;

or we disseminate promotional

materials that are found by the FDA to be false and misleading.

Under the Consolidated Appropriations Act for 2023, the FDA may use expedited

procedures to withdraw any product for which we receive accelerated approval if our confirmatory trials fail to verify the purported clinical

A failure to obtain accelerated approval or any

other form of designation or program intended to expedite product development, review or approval for any of our product candidates that

we determine to seek accelerated approval or designation for would result in a longer time to commercialization of such product candidate,

could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

We currently have Orphan Drug designation

for our product candidate for the treatment of pancreatic cancer, and may seek Orphan Drug designation for additional product candidates,

and we may be unsuccessful in obtaining or maintaining such designations.

The FDA or EMA may designate drugs for relatively

small patient populations as Orphan Drugs.

Under the standards and requirements of regulatory agencies, they may designate a product as

an Orphan Drug if it is a drug intended to treat a rare disease or condition.

In the U.S., this is generally defined as a disease with

a patient population of fewer than 200,000 individuals.

If a product with an Orphan Drug designation subsequently receives the first marketing

approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes

the EMA or FDA from approving another marketing application for the same drug for the same indication during the period of exclusivity.

The applicable period is seven years in the U.S.

and ten years in Europe.

In Europe, a product must meet the orphan prevalence not only

when so designated but at marketing authorization.

The European exclusivity period can be reduced to six years if a drug no longer meets

the criteria for Orphan Drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

We have been granted Orphan Drug designation for

our pancreatic cancer therapy in the U.S.

We have been granted Orphan Drug designation for our product candidate for the treatment of

pancreatic cancer in the U.S.

and European Union.

Orphan Drug exclusivity may be lost if a regulatory agency determines that

the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet

the needs of patients with the rare disease or condition.

Marketing exclusivity for a product designated as an Orphan Drug may not effectively

protect the product candidate from competition because different drugs can be approved for the same condition, and the same drug may be

approved for a different condition that may be used off label for an orphan indication.

Even after an Orphan Drug is approved and granted

exclusivity, the regulatory agency can subsequently approve the same drug in a different drug product for the same condition if they conclude

that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

For a description of orphan drug designation in the U.S., see “Government Regulation

– Orphan Drug Status.” For a description of orphan drug designation in the European Union, see “Government Regulation

– Regulation Outside of the U.S.

– European Union orphan designation and exclusivity.”

Although we have received Orphan Drug designation

for our pancreatic cancer product candidate, there is no guarantee that the product candidate will be successfully approved by the FDA

or the EMA for such indication, that the product, if approved, will be commercially successful in the marketplace, or that another product

will not be approved for the same indication ahead of our product candidate.

Orphan Drug exclusivity may be lost if a regulatory agency

determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of

the drug to meet the needs of patients with the rare disease or condition.

Marketing exclusivity for a product designated as an Orphan

Drug may not effectively protect the product candidate from competition because different drugs can be approved for the same rare disease

or condition, and the same drug may be approved for a different condition that may be used off-label for an orphan indication.

an Orphan Drug is approved and granted exclusivity, the regulatory agency can subsequently approve the same drug or biological substance

in a different product for the same condition if they conclude that the later product is clinically superior in that it is shown to be

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

A Fast Track by the FDA or similar designation

4 unchanged sentences

upon the data generated from our clinical trials, if allowed to proceed and if successful.

If a drug or biologic is intended for the treatment

of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical needs for this

condition, the sponsor may apply for Fast Track designation by the FDA or similar designation by another regulatory agency.

agencies have broad discretion whether to grant this designation by the FDA or similar designation by another regulatory agency.

if we believe a product candidate is eligible for this designation, we cannot assure you that a regulatory agency would decide to grant

Even if we do receive Fast Track or similar designation, we may not experience a faster development process, review or approval compared

to conventional procedures adopted by a regulatory agency.

In addition, a regulatory agency may withdraw Fast Track designation if it

believes that the designation is no longer supported by data from our clinical development program.

Many product candidates that have

received Fast Track designation have failed to obtain marketing approval.

For a description of Fast Track designation,

see Government Regulation Fast Track, Breakthrough Therapy and Priority Review Designations .

Even if we believe a product candidate is eligible

for Fast Track or any similar designation, we cannot assure you that FDA or any other regulatory agency would decide to grant it.

if we do receive Fast Track or similar designation, we may not experience a faster development process, review or approval compared to

conventional procedures adopted by a regulatory agency.

In addition, a regulatory agency may withdraw Fast Track or any similar designation

if it believes that the designation is no longer supported by data from our clinical development program.

Many product candidates that

have received Fast Track designation have failed to obtain marketing approval.

A Breakthrough Therapy designation by the

4 unchanged sentences

based upon the data we generate during our clinical trials, if successful.

For a description of Breakthrough Therapy designation, see

“Government Regulation – Fast Track, Breakthrough Therapy and Priority Review Designations.”

A Breakthrough Therapy or similar designation

is within the discretion of the FDA and other regulatory agencies.

Accordingly, even if we believe, after completing early clinical trials,

that one of our product candidates meets the criteria for designation as a Breakthrough Therapy or other similar designation, a regulatory

agency may disagree and instead determine not to make such designation.

In any event, the receipt of a Breakthrough Therapy or other similar

designation for a product candidate may not result in a faster development process, review or approval compared to drugs or biologics

considered for approval under conventional procedures of a regulatory agency and does not assure their ultimate approval.

even if one or more of our product candidates receives Breakthrough Therapy designation or other similar designations, a regulatory agency

may later decide that such product candidates no longer meet the conditions for the designation.

is within the discretion of the FDA or other applicable regulatory agencies.

Accordingly, even if we believe, after completing early clinical

trials, that one of our product candidates meets the criteria for designation as a Breakthrough Therapy or other similar designation,

a regulatory agency may disagree and instead determine not to grant such designation.

In any event, the receipt of a Breakthrough Therapy

or other similar designation for a product candidate may not result in a faster development process, review or approval compared to drugs

or biologics considered for approval under conventional procedures of a regulatory agency and does not ensure the designated product’s

ultimate approval.

In addition, even if one or more of our product candidates receives Breakthrough Therapy designation or other similar

designations, a regulatory agency may later decide that such product candidates no longer meet the conditions for the designation.

Failure to obtain marketing approval in

23 unchanged sentences

Our product candidates and the activities associated

with their development and commercialization, including their testing, manufacture, recordkeeping, labeling, storage, approval, advertising,

promotion, sale and distribution, are subject to comprehensive regulation by regulatory agencies.

The requirements that result from such

regulations include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP

requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, including

periodic inspections by regulatory agencies, requirements regarding the distribution of samples to physicians and recordkeeping.

with their development and commercialization, if approved, including their testing, manufacture, recordkeeping, labeling, storage, approval,

advertising, promotion, sale and distribution, are subject to comprehensive and ongoing regulation by regulatory agencies.

The requirements

that result from such regulations include submissions of safety and other post-marketing information and reports, registration and listing

requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records

and documents, including periodic inspections by regulatory agencies, requirements regarding the distribution of samples to physicians

and recordkeeping.

In addition, regulatory agencies may impose requirements

4 unchanged sentences

communications regarding use of their products.

If we promote our product candidates beyond their approved indications, we may be subject

to enforcement action for off-label promotion.

Violations of the laws relating to the promotion of prescription drugs or biologics may

lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection

If we promote any of our product that may receive regulatory approval beyond their approved

indications, we may be subject to enforcement action for off-label promotion.

Violations of the laws relating to the promotion of prescription

drugs or biologics may lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state

consumer protection laws.

Also, later discovery of previously unknown adverse

events or other problems with our product candidates, manufacturers or manufacturing processes, or failure to comply with regulatory requirements,

may yield various results, including:

Restrictions on such products, manufacturers or manufacturing processes;

events or other problems with our product candidates or any products that may receive regulatory approval, or our third-party manufacturers

or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

Restrictions on such products, approved manufacturers or manufacturing processes;

Restrictions on the labeling or marketing of a product;

1 unchanged sentence

Requirements to conduct post-marketing studies or clinical trials;

Warning or untitled letters or Form 483s;

Notices of noncompliance, such as warning or untitled letters from the FDA, or inspectional observations;

Withdrawal of the products from the market;

3 unchanged sentences

Suspension or withdrawal of marketing approvals;

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

Clinical hold or suspension of any of our ongoing clinical trials;

Refusal to permit the import or export of products;

Product seizure;

Injunctions or the imposition of civil or criminal penalties

Injunctions, consent decrees, or the imposition of civil or criminal penalties

Non-compliance with European requirements regarding

1 unchanged sentence

also result in significant financial penalties.

Similarly, failure to comply with the Europe’s requirements regarding the protection

of personal information can also lead to significant penalties and sanctions.

Similarly, failure to comply with EU requirements regarding the protection of personal

information can also lead to significant penalties and sanctions.

Biologics carry unique risks and uncertainties,

which could have a negative impact on future results of operations.

The successful discovery, development, manufacture,

and sale of a biologic is a long, expensive, and uncertain process.

There are unique risks and uncertainties with biologics.

access to and supply of necessary biological materials, such as cell lines, may be limited and governmental regulations restrict access

to and regulate the transport and use of such materials.

In addition, the development, manufacture, and sale of biologics is subject

to regulations that are often more complex and extensive than the regulations applicable to other pharmaceutical products.

Manufacturing

biologics, especially in large quantities, is often complex and may require the use of innovative technologies.

Such manufacturing also

requires facilities specifically designed and validated for this purpose and sophisticated quality assurance and quality control procedures.

Biologics are also frequently costly to manufacture because production inputs are derived from living animal or plant material, and some

biologics cannot be made synthetically.

Failure to successfully discover, develop, manufacture, and sell our biological product candidates,

or any biological component of our product candidates, would adversely impact our business and future results of operations.

Our relationships with customers and third-party

1 unchanged sentence

criminal sanctions, substantial civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party

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

Our future arrangements with third-party payors and customers may expose us to applicable federal and state 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 any products for which we obtain marketing approval.

Restrictions under applicable healthcare laws and regulations include

the following:

Although we do not currently have any products

on the market, upon commercialization of our drug candidates, if approved, we will be subject to additional healthcare statutory and regulatory

requirements and oversight by federal and state governments in the U.S.

as well as foreign governments in the jurisdictions in which we

conduct our business.

Physicians, other healthcare providers, and third-party payors will play a primary role in the recommendation and

prescription of any product candidates for which we obtain marketing approval.

Our future arrangements with third-party payors and customers

may expose us to broadly applicable federal and state 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 any products for which we obtain marketing

Restrictions under applicable healthcare laws and regulations include the following:

The Anti-Kickback Statute prohibits, among other

3 unchanged sentences

The False Claims Act imposes criminal and civil

penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing

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

or conceal an obligation to pay money to the Federal governments;

penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for

payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the Federal

HIPAA imposes criminal and civil liability for

3 unchanged sentences

the privacy, security and transmission of individually identifiable health information.

Federal law requires applicable manufacturers

of covered drugs to report payments and other transfers of value to physicians and teaching hospitals, which includes data collection

and reporting obligations.

The information is to be made publicly available on a searchable website.

Analogous state and foreign 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.

The Physician Payments Sunshine Act requires applicable

manufacturers of covered drugs to report payments and other transfers of value to physicians, certain advanced non-physician healthcare

practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family, which

includes data collection and reporting obligations.

Such information reported to CMS is made publicly available on a searchable website.

Analogous state and foreign 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.

Some state laws require pharmaceutical companies

20 unchanged sentences

prices we may obtain.

The United States and many foreign jurisdictions

have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably

sell our product candidates, if approved.

The United States government, state legislatures and foreign governments also have shown significant

interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls,

restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs and biologics.

The Affordable Care Act was intended to broaden

access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency

requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional

health policy reforms.

We expect that the Affordable Care Act, as well

as other healthcare reform measures that have and 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 our product candidates, if approved, and could seriously harm our future revenues.

Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from

private payers.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate

revenue, attain and maintain profitability of our product candidates, if approved.

Governments outside the U.S.

tend to impose

strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the EEA countries

and the United Kingdom, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations

with governmental authorities can take considerable time after the receipt of marketing approval for a product.

To obtain reimbursement

or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product

candidate to other available therapies.

If reimbursement of our product candidates is unavailable or limited in scope or amount, or if

pricing is set at unsatisfactory levels, our business could be materially harmed.

All aspects of our business, including research

and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation

and regulation.

Changes in applicable U.S.

federal and state laws and agency regulation, as well as foreign laws and regulations, could

have a materially negative impact on our business.

and in some other jurisdictions, there have been a number of legislative

and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product

candidates or any of our potential future product candidates, restrict or regulate post-approval activities, or affect our ability to

profitably sell any product candidates for which we obtain marketing approval.

Increased scrutiny by the U.S.

Congress of the

FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling

and post-marketing testing and other requirements.

Congress also must reauthorize the FDA’s user fee programs every five years and

often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA and industry

stakeholders as part of this periodic reauthorization process.

Congress most recently reauthorized the user fee programs in September

2022 without any substantive policy changes.

Among policy makers and payors in the U.S.

elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs,

improving quality and/or expanding access.

In the U.S., the pharmaceutical industry has been a focus of these efforts and has been significantly

affected by major legislative initiatives.

In March 2010, Congress passed the ACA, which substantially changed the way healthcare is financed

by both the government and private insurers, and significantly impacts the U.S.

pharmaceutical industry.

Following several years of litigation

in the federal courts, in June 2021, the U.S.

Supreme Court upheld the ACA when it dismissed a legal challenge to the law’s constitutionality.

Further legislative and regulatory changes under the ACA remain possible, although it is unknown what form any such changes or any law

would take, and how or whether it may affect the pharmaceutical industry as a whole or our business in the future.

We expect that changes

or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with

regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare

industry in the U.S.

Further, over the past several years there has

been heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products,

which has resulted in several U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other

things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform

government program reimbursement methodologies for drug products.

The probability of success of these policies, many of which have been

subjected to legal challenge in the federal court system, and their potential impact on the U.S.

prescription drug marketplace is unknown.

There are likely to be continued political and legal challenges associated with implementing these reforms as they are currently envisioned.

Additionally, on December 20, 2019, the Further

Consolidated Appropriations Act for 2020 was signed into law (P.L.

116-94) and includes a piece of bipartisan legislation called the Creating

and Restoring Equal Access to Equivalent Samples Act of 2019 (the “CREATES Act”).

The CREATES Act aims to address the concern

articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their

products, including by invoking the existence of a REMS for certain products, to deny generic product developers access to samples of

brand products.

Because generic product developers need samples of a reference listed drug, to conduct certain comparative testing required

by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products.

this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer

to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product

developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain

highly uncertain and its potential effects on any of our future commercial products are unknown.

In addition, many states have proposed or enacted

legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as by requiring biopharmaceutical manufacturers

to publicly report proprietary pricing information or to place a maximum price ceiling on pharmaceutical products purchased by state agencies.

For example, in recent years, several states have formed PDABs.

Much like the IRA’s drug price negotiation program, these PDABs

have attempted to implement UPLs on drugs sold in their respective states in both public and commercial health plans.

In August 2023,

Colorado’s PDAB announced a list of five prescription drugs that would undergo an affordability review.

The effects of these efforts

remain uncertain pending the outcomes of several federal lawsuits challenging state authority to regulate prescription drug payment limits.

In December 2020, the U.S.

Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate PBMs

and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive

efforts by states in this area.

The FTC in mid-2022 also launched sweeping investigations into the practices of the PBM industry that

could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks,

or financial arrangements.

Significant efforts to change the PBM industry as it currently exists in the U.S.

may affect the entire pharmaceutical

supply chain and the business of other stakeholders, including biopharmaceutical developers like us.

In the European Union, similar political, economic

and regulatory developments may affect our ability to profitably commercialize our products.

In addition to continuing pressure on prices

and cost containment measures, legislative developments at the European Union or EU member state level may result in significant additional

requirements or obstacles that may increase our operating costs.

We cannot predict the likelihood, nature or extent

of government regulation that may arise from future legislation or administrative or executive action.

We expect that additional federal

and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments

will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products,

once approved, or additional pricing pressures.

Even if we are able to commercialize any

of our drug candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare

reform initiatives, which would harm our business.

The regulations that govern marketing approvals,

pricing, coverage and reimbursement for new drug and biological products vary widely from country to country.

Current and future legislation

may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries

require approval of the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing

approval is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing governmental control even

after initial approval is granted.

As a result, we may obtain marketing approval for a product in a particular country, but then be subject

to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues

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

Adverse pricing limitations may hinder our ability to recoup our

investment in one or more product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize any product candidates

successfully also will depend in part on the extent to which coverage and reimbursement for these product candidates and related treatments

will be available from government authorities, private health insurers and other organizations.

In the U.S., reimbursement varies from

payor to payor.

Reimbursement agencies in Europe may be more conservative than federal healthcare programs or private health plans in

For example, a number of cancer drugs are generally covered and paid for in the U.S.

but have not been approved for reimbursement

in certain European countries.

A primary trend in the U.S.

healthcare industry and elsewhere is cost containment.

Government authorities

and third-party payors have attempted to control costs by limiting coverage and the amount of payments for particular products.

payors may limit coverage to specific drug products on an approved list, also known as a formulary, which might not include all of the

FDA-approved drugs for a particular indication.

Payors may require use of alternative therapies or a demonstration that a product is medically

necessary for a particular patient before use of a product will be covered.

Additionally, payors may seek to control utilization by imposing

prior authorization requirements.

Increasingly, third-party payors are requiring

that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for products.

cannot be sure that coverage will be available for any product candidate that we commercialize and, if coverage is available, what the

level of reimbursement will be.

Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing

Patients are unlikely to use our products, if they are approved for marketing, unless coverage is provided and reimbursement

is adequate to cover a significant portion of the cost of such products.

There may be significant delays in obtaining coverage

and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which the drug is approved

by the FDA, EMA, or other comparable regulatory agencies.

Moreover, eligibility for reimbursement does not imply that any drug will be

paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.

reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Reimbursement

rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already

set for lower cost drugs and may be incorporated into existing payments for other services.

Net prices for drugs and biologics may be

reduced by mandatory discounts or rebates required by federal healthcare programs or private payors and by any future relaxation of laws

that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S.

In the U.S., third-party

payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies.

In the European Union,

reference pricing systems and other measures may lead to cost containment and reduced prices.

Our inability to promptly obtain coverage

and profitable payment rates from both government-funded and private payors for any approved products that we develop could have a material

adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Further, there have been, and may continue to

be, legislative and regulatory proposals at the U.S.

federal and state levels and in foreign jurisdictions directed at broadening the

availability and containing or lowering the cost of healthcare.

The continuing efforts of the government, insurance companies, managed

care organizations and other third-party payors to contain or reduce costs of healthcare may adversely affect our ability to set prices

for our products that would allow us to achieve or sustain profitability.

In addition, governments may impose price controls on any of

our products that obtain marketing approval, which may adversely affect our future profitability.

Most recently, in August 2022, President Biden

signed into the law the Inflation Reduction Act of 2022, or the IRA.

Among other things, the IRA has multiple provisions that may impact

the prices of drug products that are both sold into the Medicare program and throughout the U.S.

Starting in 2023, a manufacturer of drugs

or biological products covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price

increases faster than the rate of inflation.

This calculation is made on a drug product-by-drug product basis and the amount of the rebate

owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.

Additionally,

starting for payment year 2026, the Centers for Medicare & Medicaid Services, or CMS, will negotiate drug prices annually for a select

number of single source Part D drugs without generic or biosimilar competition.

CMS will also negotiate drug prices for a select number

of Part B drugs starting for payment year 2028.

If a drug product is selected by CMS for negotiation, it is expected that the revenue

generated from such drug will decrease.

Additional state and federal healthcare reform measures are expected to be adopted in the future,

any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result

in reduced demand for certain biopharmaceutical products or additional pricing pressures.

In some foreign countries, particularly the member

states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing

negotiations with governmental authorities can be a long and expensive process after the receipt of marketing approval for a drug candidate.

In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as

part of cost containment measures.

Political, economic and regulatory developments may further complicate pricing negotiations, and pricing

negotiations may continue after reimbursement has been obtained.

Reference pricing used by various European Union member states and parallel

distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

In some countries, we may be required

to conduct additional clinical trials that compare the cost-effectiveness of our drug candidates to other available therapies in order

to obtain reimbursement or pricing approval.

Publication of discounts by third-party payors or authorities may lead to further pressure

on prices or reimbursement levels within the country of publication and other countries.

If reimbursement of our products is unavailable

or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to successfully

commercialize and achieve or sustain profitability for sales of any of our drug candidates that are approved for marketing in that country

and our business could be adversely affected.

Risks Related to the Commercialization of Our Product Candidates

60 unchanged sentences

Clinical trials of our product candidates, if

allowed to proceed, will be conducted in carefully defined subsets of patients who have agreed to enter a clinical trial.

Consequently,

it is possible that our clinical trials, if allowed to proceed, may indicate an apparent positive effect of a product candidate that is

greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

If, following approval of

a product candidate, we or others discover that the product candidate is less effective than previously believed or causes undesirable

side effects that were not previously identified, any of the following adverse events could occur:

allowed to proceed, will be conducted in carefully defined subsets of patients who have provided informed consent to enter a clinical

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

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

If, following

approval of a product candidate, we or others discover that the product candidate is less effective than previously believed or causes

undesirable side effects that were not previously identified, any of the following could occur:

A regulatory agency may withdraw its approval of the product candidate or seize the product candidate;

60 unchanged sentences

including Austrianova in which we own an equity interest.

We expect to continue to rely heavily on third parties, such as a CRO, a clinical

data management organization, a medical institution, a clinical investigator and others to plan for and conduct our clinical trials.

agreements with these third parties generally allow the third party to terminate our agreement with them at any time.

If we are required

to enter alternative arrangements because of any such termination, the introduction of our product candidates to market could be delayed.

We expect to continue to rely heavily on third parties, such as contract research

organizations (“CROs”), clinical data management organizations, medical institutions (including academic medical centers),

clinical investigators and others to plan for and conduct our clinical trials.

Our agreements with these third parties generally allow

the third party to terminate our agreement with them at any time.

Switching or adding third parties to conduct our studies involves substantial

cost and requires extensive management time and focus.

We may be forced to seek an engagement with a substitute or new third party and may

be unable to enter into arrangements with such third parties on commercially reasonable terms, or at all.

If we are required to enter

alternative arrangements because of any such termination, the development, marketing authorization, or introduction of our product candidates

to market could be delayed.

Our reliance on these third parties for R&D

3 unchanged sentences

for the trial.

Moreover, regulatory agencies require us to comply with current good manufacturing practices (“cGMP”) for conducting,

recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the

rights, integrity and confidentiality of trial participants are protected.

Our reliance on third parties that we do not control does not

relieve us of these responsibilities and requirements.

We also are required to register ongoing clinical trials and post the results of

completed clinical trials on a government-sponsored database of regulatory agencies within specified timeframes.

Failure to do so can

result in fines, adverse publicity and civil and criminal sanctions.

Moreover, regulatory agencies require us to comply with GCP for conducting, recording and reporting the results of clinical

trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial

participants are protected.

Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements.

Regulatory agencies enforce GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites.

we or any of our contractors fail to comply with applicable GCP regulations, the clinical data generated in the applicable trial may be

deemed unreliable and regulatory agencies may require us to perform additional clinical trials before approving a drug candidate for marketing,

which we may not have sufficient cash or other resources to support and which would delay our ability to generate revenue from future

sales of such drug candidate.We also are required to register ongoing clinical trials and post the results of completed clinical trials

on a government-sponsored database of regulatory agencies within specified timeframes.

Failure to do so can result in fines, adverse publicity

and civil and criminal sanctions.

Furthermore, these third parties may also have

relationships with other entities, some of which may be our competitors.

If these third parties do not successfully carry out their contractual

duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of a regulatory agency or our protocols,

we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to,

or may be delayed in our efforts to, successfully commercialize our product candidates.

relationships with other entities, some of which may be our competitors, and we will be unable to control whether or not our contracted

third parties devote sufficient time and resources to our preclinical and clinical programs.

If these third parties do not successfully

carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of a regulatory

agency or our protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates

and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

In addition, disruptions in the global economy

93 unchanged sentences

manufacturers for the manufacturing of our products.

However, there can be no assurance that we will be able to maintain our relationships

with such third-party manufacturers on commercially reasonable terms, if at all.

If we are unable to maintain those relationships, we

could experience delays in our development efforts as we locate and qualify new third-party manufacturers.

In order to conduct planned or future clinical

13 unchanged sentences

In addition, the manufacturing process for any

products that we may develop is subject to FDA, EMA and foreign regulatory authority approval processes and continuous oversight, and

we will need to contract with manufacturers who can meet all applicable FDA, EMA and foreign regulatory authority requirements, including

complying with current good manufacturing processes, or on an ongoing basis.

If we or our third-party manufacturers are unable to reliably

produce products to specifications acceptable to the FDA, EMA or other regulatory authorities, we may not obtain or maintain the approvals

we need to commercialize such products.

Even if we obtain regulatory approval for any of our product candidates, there is no assurance

that either we or our third-party manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA,

EMA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product,

or to meet potential future demand.

Any of these challenges could delay initiation and completion of clinical trials, require bridging

clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate,

impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, prospects, financial condition,

results of operations and growth prospects.

products that we may develop is subject to FDA, EMA and other comparable foreign regulatory authority approval processes and continuous

oversight, and we will need to contract with manufacturers who can meet all applicable legal and regulatory requirements, including compliance

with cGMP, on an ongoing basis.

If we or our third-party manufacturers are unable to reliably produce products to specifications acceptable

to the FDA, EMA or other comparable regulatory authorities, we may not obtain or maintain the approvals we need to commercialize such

Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our third-party

manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA, EMA or other comparable regulatory

authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential

future demand.

Any of these challenges could delay initiation and completion of clinical trials, require bridging clinical trials or the

repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization

efforts, increase our cost of goods, and have an adverse effect on our business, prospects, financial condition, results of operations

and growth prospects.

Furthermore, our third-party manufacturers are

subject to inspection and approval by regulatory agencies before we can obtain regulatory approval and commercially launch of any of our

product candidates, and thereafter are subject to ongoing inspection from time to time.

Our failure, or the failure of our third-party

manufacturers, to comply with applicable regulations could result in enforcement actions, such as the issuance of inspectional observations

or notices of noncompliance, or sanctions being imposed on us, including clinical holds, injunctions, civil penalties, suspension or withdrawal

of approvals, seizures or recalls of products, operating restrictions or criminal prosecutions, any of which could significantly and adversely

affect supplies of our products.

Any such failure by us or any of our third-party manufacturers would significantly impact our ability

to develop, obtain regulatory approval for or, if approved, market our products.

Risks Related to our Intellectual Property

3 unchanged sentences

other intellectual property rights to our product candidates in all countries throughout the world would be prohibitively expensive, and

our intellectual property rights in some countries outside the United States can be less extensive than those in the United States or

non-existent.

For example, the Melligen cells are protected by patents only in the U.S.

and Europe and we are only pursuing patent protection

for our pancreatic cancer product candidate in the U.S., Australia and Canada.

our intellectual property rights in some countries outside the U.S.

can be less extensive than those in the U.S.

or non-existent.

example, the Melligen cells are protected by patents only in the U.S.

and Europe and we are only pursuing patent protection for our pancreatic

cancer product candidate in the U.S., Australia and Canada.

Many companies have encountered significant problems

28 unchanged sentences

methods using the same expired on March 27, 2017.

Currently, we do not have any issued patents in any countries covering our product candidate

for the treatment of pancreatic cancer.

We exclusively license from UTS patented Melligen cells, which cover our product candidate for

the treatment of diabetes, which are issued in the U.S.

and Europe and expire in August 2028.

Currently, we do not have any issued patents

or pending applications covering our product candidate for the treatment of cancer using cannabinoids or our product candidate for the

treatment of malignant ascites fluid therapy.

We may not be able to obtain protection for our product candidates or variations of our

product candidates.

We may not be able to obtain protection for our product candidates or variations of

our product candidates.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide

41 unchanged sentences

capsules encapsulating cells expressing cytochrome P450 and treatment methods using the same.

These patents expired on March 27, 2017.

We exclusively license, from UTS, patented Melligen cells, which cover our product candidate for the treatment of diabetes.

are issued in the U.S.

and Europe and expire in August 2028.

Currently, we do not have any issued patents in any countries covering our

product candidate for the treatment of cancer;

we have pending applications in the U.S., Australia and Canada and relating to our product

candidate for the treatment of pancreatic cancer.

The patents are issued in the U.S.

and expire in August 2028.

Currently, we do not have any issued patents in any countries covering our product candidate for the treatment

we have pending applications in the U.S., Australia and Canada and relating to our product candidate for the treatment of pancreatic

If issued, such patents would expire in March 2038.

128 unchanged sentences

We have licensed rights to intellectual property

from third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC and diabetes.

If we materially breach or fail to perform any provision under these license and collaboration agreements, including failure to make payments

to a licensor or collaborator when due for royalties and failure to use commercially reasonable efforts to develop and commercialize our

product candidates, such licensors and collaborators have the right to terminate our agreements, and upon the effective date of such termination,

our right to practice the licensed intellectual property would end.

Any uncured, material breach under the agreements could result in

our loss of rights to practice the patent rights and other intellectual property licensed to us under the agreements and could result

in the loss of our ability to develop or commercialize our product candidates.

from third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC.

If we materially

breach or fail to perform any provision under these license and collaboration agreements, including failure to make payments to a licensor

or collaborator when due for royalties and failure to use commercially reasonable efforts to develop and commercialize our product candidates,

such licensors and collaborators have the right to terminate our agreements, and upon the effective date of such termination, our right

to practice the licensed intellectual property would end.

Any uncured, material breach under the agreements could result in our loss of

rights to practice the patent rights and other intellectual property licensed to us under the agreements and could result in the loss

of our ability to develop or commercialize our product candidates.

We may need to license certain intellectual

248 unchanged sentences

foreign officials.

Additionally, in many countries outside the U.S., the health care providers who prescribe pharmaceuticals are employed

Additionally, in many countries outside the U.S., the healthcare providers who prescribe pharmaceuticals are employed

by the government and the purchasers of pharmaceuticals are government entities;

15 unchanged sentences

Any such violations

could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation,

our brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results

could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our

brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results

and financial condition.

79 unchanged sentences

decreased ability to issue additional shares of our common stock or obtain additional financing in the future.

A large number of shares may be issued and subsequently sold

upon the exercise of existing options and warrants and upon the conversion of the Series B Preferred Stock.

As of July 25, 2023, there were 281,269 shares

A large number of shares may be issued and

subsequently sold upon the exercise of existing options and warrants and upon the conversion of the Company’s Series B convertible

preferred stock (the “Series B Preferred Shares”).

As of August 8, 2024, there were 925,164 shares

of common stock issuable under outstanding options, 18,570,847 shares of common stock issuable upon exercise of outstanding warrants at

various exercise prices and 68,183,469 shares of common stock reserved for issuance upon conversion of the Series B Preferred Stock.

the extent that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants, the market

price of our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances of shares

of common stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further decline

in the market price.

various exercise prices and 3,765,105 shares of common stock reserved for issuance upon conversion of the Preferred Shares.

To the extent

that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants, the market price of

our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances of shares of common

stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further decline in the market

The requirement

that we redeem the Series B Preferred Stock in cash could adversely affect our business plan, liquidity, financial condition, and results

that we redeem the Series B Preferred Shares in cash could adversely affect our business plan, liquidity, financial condition, and results

of operations.

If not converted, we are required to redeem some

or all of the outstanding shares of Series B Preferred Stock for cash under certain circumstances.

or all of the outstanding shares of Series B Preferred Shares for cash under certain circumstances.

These obligations could have important

1 unchanged sentence

In particular, they could:

· limit our flexibility in planning

for, or reacting to, changes in our businesses and the industries in which we operate;

· increase our vulnerability to

general adverse economic and industry conditions;

· place us at a competitive disadvantage

compared to our competitors.

limit our flexibility in planning for, or reacting to, changes in our businesses and the industries in which we operate;

increase our vulnerability to general adverse economic and industry conditions;

place us at a competitive disadvantage compared to our competitors.

No assurances can be given that we will be successful

in making the required payments to the holders of the Series B Preferred Stock or that we will be able to comply with the financial or

in making the required payments to the holders of the Series B Preferred Shares or that we will be able to comply with the financial or

other covenants contained in the Certificate of Designations.

1 unchanged sentence

with the Certificate of Designations:

· dividends will accrue on the

Series B Preferred Stock at 15% per annum;

· the holders of the Series B

Preferred Stock could foreclose against our assets;

· we could be forced into bankruptcy

or liquidation.

dividends will accrue on the Series B Preferred Shares at 15% per annum;

the holders of the Series B Preferred Shares could foreclose against our assets;

we could be forced into bankruptcy or liquidation.

The terms of the

Series B Preferred Stock could limit our growth and our ability to finance our operations, fund our capital needs, respond to changing

Series B Preferred Shares could limit our growth and our ability to finance our operations, fund our capital needs, respond to changing

conditions and engage in other business activities that may be in our best interests.

28 unchanged sentences

Government regulation of drug pricing.

The price of our common stock is volatile,

which substantially increases the risk that our investors may not be able to sell their shares at or above the price that the investors

have paid for their shares.

The price of our

common stock is volatile, which substantially increases the risk that our investors may not be able to sell their shares at or above the

price that the investors have paid for their shares.

Because of the price volatility in our shares,

1 unchanged sentence

a price the investors desire to attain.

Over the past twelve months, shares of our common stock were quoted and traded at a high of $3.10

per share and a low of $1.95 per share.

The inability to sell securities in a rapidly declining market may substantially increase the

risk of loss because the price of our common stock may suffer greater declines due to the historical price volatility of our shares.

factors, some of which are beyond our control, which may cause our share price to fluctuate significantly include, but are not limited

to, the following:

During the year ended April 30, 2024, shares of our common stock were quoted and traded at a high

of $3.23 per share and a low of $1.92 per share.

The inability to sell securities in a rapidly declining market may substantially increase

the risk of loss because the price of our common stock may suffer greater declines due to the historical price volatility of our shares.

Certain factors, some of which are beyond our control, which may cause our share price to fluctuate significantly include, but are not

limited to, the following:

Variations in our quarterly operating results;

12 unchanged sentences

attention and resources, which could have a material adverse effect on us and the trading price of our common stock.

We have no plans to pay dividends in the

foreseeable future, and investors may not expect a dividend as a return of or on any investment in us.

We have no plans to pay dividends

in the foreseeable future, and investors may not expect a dividend as a return of or on any investment in us.

We have not paid dividends on our shares of common

1 unchanged sentence

In addition, the terms of the certificate of designations

governing our Series B convertible preferred stock presently restricts our ability to pay dividends.

We are a “smaller reporting company” under the SEC’s

disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

We are a “smaller reporting company” under the SEC’s

governing our Preferred Shares presently restricts our ability to pay dividends.

We are a “smaller reporting

company” under the Commission’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable

to smaller reporting companies.

We are a “smaller reporting company” under the Commission’s

disclosure rules, meaning that we have either:

4 unchanged sentences

As a smaller reporting company, we are permitted

to comply with scaled-back disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations

regarding executive compensation in our periodic reports and proxy statements.

We have elected to adopt the accommodations available to

smaller reporting companies.

Until we cease to be a smaller reporting company, the scaled-back disclosure in our SEC filings will result

in less information about our company being available than for other public companies.

to comply with scaled-back disclosure obligations in our Commission filings compared to other issuers, including with respect to disclosure

obligations regarding executive compensation in our periodic reports and proxy statements.

We have elected to adopt the accommodations

available to smaller reporting companies.

Until we cease to be a smaller reporting company, the scaled-back disclosure in our Commission

filings will result in less information about our company being available than for other public companies.

If investors consider our common stock less attractive

11 unchanged sentences

trading price for our common stock may be negatively affected.

We face risks related to owning securities

issued by other public companies.

We own securities of other public companies, including

the Notes, the MYMD Preferred Shares, the Femasys Warrants and the MyMD Warrants.

Management’s Discussion and

Analysis of Financial Condition and Results of Operations – Femasys Transaction” and “– MyMD Transaction”

for more information regarding these securities.

Defined terms used in this risk factor are defined in such section.

The Notes are convertible at a conversion price

of $1.18 per share.

To the extent we convert the Notes when the market price of the Femasys Shares is lower than the conversion price,

we may realize a loss equal to the difference between the conversion price and the market price.

Femasys may require us to convert our

Notes into Femasys Shares if the closing price of the Femasys Shares exceeds $2.36 per share for 10 consecutive trading days and the daily

dollar trading volume of the Femasys Shares exceeds one million dollars ($1,000,000) per day during the same period and certain equity

conditions described in the Notes are satisfied.

If we are forced to mandatorily convert the Notes, we may realize additional loss.

The MyMD Preferred Shares are convertible at a

conversion price of $1.816 per share.

To the extent we convert the MyMD Preferred Shares when the market price of the MyMD Common Shares

is lower than the conversion price, we may realize a loss equal to the difference between the conversion price and the market price.

The Series A Warrants are exercisable at an exercise

price of $1.18 per share, and the Series B Warrants are exercisable at an exercise price of $1.475.

There can be no assurance that the

Femasys Warrants will be in the money when exercisable, and as such they may expire worthless.

The MyMD Warrants are exercisable at an exercise

price of $1.816 per share.

There can be no assurance that the MyMD Warrants will be in the money when exercisable, and as such they may

expire worthless.

Our ownership of securities of other companies

creates a risk that we will be categorized as an investment company that is subject to registration under the Investment Company Act of

1940 (the “1940 Act”).

If we are deemed to be an investment company under the 1940 Act, we may be required to institute burdensome

compliance requirements and our activities may be restricted, which may make it difficult for us to continue operating our business.

Section 3(a)(1)(A) of the 1940 Act defines an

“investment company” as any issuer that is or holds itself out as being, engaged primarily, or proposes to engage primarily,

in the business of investing, reinvesting or trading in securities.

Section 3(a)(1)(C) of the 1940 Act defines “investment company”

to mean any issuer that is engaged or proposes to engage in the business of investing, reinvesting, owning, holding, or trading in securities,

and owns or proposes to acquire investment securities having a value exceeding 40% of the value of such issuer’s total assets.

investment companies are required to register and meet other requirements promulgated under the 1940 Act.

Our purchases of securities

of other companies, including pursuant to the Femasys Transaction and the MyMD Transaction (each as defined below), could give rise to

a determination that we are or were an investment company subject to registration under the 1940 Act.

Such a determination could have

a material adverse effect on our business operations, projected revenues and earnings, and growth prospects.

We believe that we are not an investment company,

and we have conducted and intend to continue to conduct our operations so that we will not be deemed to be an investment company.

if we were deemed to be an investment company under the 1940 Act, our future activities may be restricted, including:

· restrictions on the nature of our investments;

· restrictions on the issuance of securities, each of which may make it difficult for us to conduct our

business and raise working capital.

In addition, we may have imposed upon us burdensome

requirements, including:

· registration as an investment company with the Commission;

· adoption of a specific form of corporate structure different from our current operating structure;

· reporting, record keeping, voting, proxy and disclosure requirements and other rules and regulations that

we are currently not subject to.

Compliance with these additional regulatory burdens would require additional

expenses for which we have not allotted funds and may hinder our ability to operate our business, and make it impractical for us to continue

our business as contemplated and could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Employee and Tax Matters,

49 unchanged sentences

in varying amounts beginning in 2024.

Under Sections 382 and 383 of the United States Internal Revenue Code of 1986, as amended, or the

Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” (generally defined as a

greater than 50-percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year

period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to

offset its post-change taxable income or taxes will be limited to approximately $19 million and $6 million for federal and state, respectively.

Under Sections 382 and 383 of the U.S.

Internal Revenue Code of 1986, as amended, or the Code, and

corresponding provisions of state law, if a corporation undergoes an “ownership change,” (generally defined as a greater than

50-percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year period), the

corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change

taxable income or taxes will be limited to approximately $20 million and $11 million for federal and state, respectively.

We experienced ownership changes in the past and

29 unchanged sentences

caused extreme volatility and disruptions in the capital and credit markets.

Also, geopolitical tensions and the conflict between Russia

and Ukraine continue to escalate, and numerous jurisdictions have imposed harsh sanctions on certain industry sectors and parties in Russia,

as well as enhanced export controls on certain products and industries.

These and any additional sanctions and export controls, as well

as any counter responses by the governments of Russia or other jurisdictions, could adversely affect, directly or indirectly, the global

supply chain, with negative implications on the availability and prices of raw materials, energy prices, and our customers, as well as

the global financial markets and financial services industry.

Also, geopolitical tensions and the conflicts between Russia

and Ukraine and between Israel and Palestine continue to escalate, and numerous jurisdictions have imposed harsh sanctions on certain

industry sectors and parties in Russia, as well as enhanced export controls on certain products and industries.

These and any additional

sanctions and export controls, as well as any counter responses by the governments of Russia or other jurisdictions, could adversely affect,

directly or indirectly, the global supply chain, with negative implications on the availability and prices of raw materials, energy prices,

and our customers, as well as the global financial markets and financial services industry.

A severe or prolonged economic downturn, such

33 unchanged sentences

general social, economic and political conditions in these foreign markets.

UNRESOLVED 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