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Item 1A. Risk Factors

2025-06-30 compared with 2024-04-08 · 605 added, 658 removed, 13 unchanged (99% of the section changed)

9 unchanged sentences

operating results and prospects.

statements below are forward-looking statements.

For additional information, see the section of this Annual Report under the caption

“Cautionary Note Regarding Forward-Looking Statements.”

Related to Our Business Generally

business strategy is high-risk

are focusing our resources and efforts on development of drug product candidates, which requires extensive cash needs for research and

development activities.

This is a high-risk strategy because there is no assurance that that our cash resources will be adequate to develop

our product candidates, that our product candidates will ever be proven to be safe and effective or that any products will ever become

commercially viable.

This makes our stock an unsuitable investment for many investors.

do not currently have enough working capital to execute our strategic plan .

have suffered recurring losses from operations, and we are now essentially a non-revenue company.

We will need capital to maintain our

operations and to support our intended development of our therapeutics business.

Future financings will be necessary in order for us

to survive as a going concern and to properly execute our strategic plan.

However, there can be no assurance that such future financings

will be available to us (or, if they are, that they can be consummated on desirable terms).

may, in the short and long-term, seek to raise capital through the issuance of equity securities or through other financing sources.

To the extent that we seek to raise additional funds by issuing equity or equity-linked securities, our stockholders may (as has already

occurred several times) experience significant dilution.

Any debt financing, if available, may include financial and other covenants

that could restrict our use of the proceeds from such financing or impose other business and financial restrictions on us.

we may consider alternative approaches such as licensing, joint venture, or partnership arrangements to provide short term or long term

Additional funding may not be available to us on acceptable terms, or at all.

In addition, any future financing (depending on

the terms and conditions) may be subject to the approval of Alpha, a related party and the holder of our 8% Senior Convertible Debenture

and of our 8% Convertible Debenture (together, the “Debentures”), and/or trigger certain adjustments to the conversion prices

of the Debentures or to the exercise prices of warrants held by Alpha and/or by other persons.

See Part II, Item 7 “ Management’s

Discussion and Analysis of Financial Condition and Results of Operations ” for additional details regarding the Debentures.

our debt will require a significant amount of cash, and we do not expect to have sufficient cash flow from our business to pay this debt.

ability to make payments to Alpha of principal or interest on the Debentures or to make any potential

prepayments for the Debentures, to the extent applicable, depends on our future performance, which is subject to economic, financial,

competitive and other factors beyond our control.

Our cash resources currently on hand, plus any anticipated near-term cash flow from

operations or dispositions, would not be sufficient to service our indebtedness and/or to make necessary expenditures.

December 2022, we entered into a Securities Purchase Agreement with Alpha and in exchange for $3,000,000 in cash (less $50,000 for expense

reimbursement) issued to Alpha our 8% Senior Convertible Debenture with an original face amount of $3,300,000 due on December 22, 2025

(the “2022 Debenture”), plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through June 22, 2028) at $1.65

Commencing June 1, 2023 and continuing on the first day of each month thereafter until

the earlier of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption

Date”), we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022

Debenture (the “Monthly Redemption Amount”).

The Monthly Redemption Amount must be paid in cash;

provided that after the

first two monthly redemptions, we may (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived)

elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the

lesser of (i) the then applicable conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the

2022 Debenture) for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption

2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly

Interest may be paid in cash or shares of common stock or a combination thereof at our option;

provided that the Equity Conditions

have been satisfied.

has waived the Equity Conditions for certain Monthly Redemption Amounts, but Alpha is not required to continue such waivers beyond May

For the foreseeable future, we do not expect to be able to satisfy the Equity Conditions;

as a result, where there is no waiver

of the Equity Conditions we would not have the opportunity to make 2022 Debenture payments in the form of stock rather than in the form

of cash, even for types of payments for which payment in the form of stock would have been allowed.

2022 Debenture is convertible into our common stock at any time at the holder’s option;

the conversion price was originally $1.32

but pursuant to a Securities Purchase Agreement amendment in December 2023 it was reduced to $0.73 and then in February 2024 it was adjusted

downward to $0.26 per share by virtue of the operation of a “ratchet” antidilution provision.

(The exercise price of the

warrants issued with the 2022 Debenture was originally $1.65 but pursuant to a Securities Purchase Agreement amendment in December 2023

it was reduced to $0.73 and then in February 2024 it was adjusted downward to $0.26 per share by virtue of the operation of a “ratchet”

antidilution provision.)

than the Monthly Redemption Amounts, the 2022 Debenture does not call for scheduled payments of principal before the scheduled maturity

the 2022 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to their conversion price

and exercise price.

the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

61 days’ notice to the Company.

granted Alpha resale registration rights for the common shares underlying the 2022 Debenture and the accompanying warrants.

December 2023 amendment of the 2022 Debenture conversion price (and the accompanying warrants’ exercise price) to be $0.73 per

share resulted in the 2022 Debenture’s then current $1,528,922 principal amount thereof becoming convertible into 2,094,414 shares

of Company common stock (as opposed to the 1,158,274 shares into which such outstanding principal amount was convertible pre-adjustment).

Also, the December 2023 amendment triggered a “ratchet” antidilution adjustment in the Company’s outstanding “exploding”

“Series C Warrants,” resulting in such Series C Warrants becoming exercisable for 455,623 common shares (at an exercise price

of $0.73 per share), as opposed to the 251,971 common shares into which such outstanding Series C Warrants would have been exercisable

(at $1.32 per share) pre-adjustment.

Finally, the $0.73 price triggered a “ratchet” antidilution adjustment in the exercise

price of other outstanding Company common stock warrants, including 7,048 warrants held by Alpha and 67,620 warrants held by other persons,

which were previously exercisable at $1.32 per share.

February 2024, we entered into a Securities Purchase Agreement with Alpha and in exchange for $500,000 in cash (less $25,000 for expense

reimbursement) issued to Alpha an 8% Convertible Debenture with a face amount of $550,000 due on December 31, 2024 (the “2024 Debenture”),

plus 900,016 5-year common stock warrants exercisable at $0.26 per share.

In addition, per this Securities Purchase Agreement Alpha obtained

an option to purchase additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000 (and

with a proportional number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional warrants), which

would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).

This option is valid through July 1, 2024.

2024 Debenture has a maturity date of December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option,

into shares of our common stock, at $0.6111 per share.

The 2024 Debenture does not call for scheduled

payments of principal or interest before the scheduled maturity date.

Interest on the 2024 Debenture accrues on its outstanding

principal balance at the rate of 8% per annum.

the 2024 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to the Conversion Price and

Exercise Price.

the 2024 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

61 days’ notice to the Company.

granted Alpha “piggyback” registration rights for the common shares underlying the 2024 Debenture and the accompanying warrants.

$0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in the

2022 Debenture, resulting in the then current $1,198,922 principal amount thereof becoming convertible into 4,611,238 shares of Company

common stock (as opposed to the 1,642,359 shares into which such outstanding principal amount were convertible pre-adjustment).

the $0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in

the Company’s outstanding “exploding” “Series C Warrants,” resulting in such Series C Warrants becoming

exercisable for 1,279,261 common shares (at an exercise price of $0.26 per share), as opposed to the 455,623 common shares into which

such outstanding Series C Warrants would have been exercisable (at $0.73 per share) pre-adjustment.

Finally, the $0.26 exercise price

of the Warrant would trigger a “ratchet” antidilution adjustment in the exercise price of other outstanding Company common

stock warrants, including 2,507,048 warrants held by Alpha and 67,620 warrants held by other persons, all of which were previously exercisable

at $0.73 per share.

we continue to lack cash resources sufficient

to service our indebtedness, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or issuing

additional equity, equity-linked or debt instruments on terms that may be onerous or highly dilutive.

Our ability to refinance our indebtedness

will depend on the capital markets and our financial condition at such time.

If we are unable to engage in any of these activities or

engage in these activities on desirable terms, we may be unable to meet our debt obligations, which would materially and adversely impact

our business, financial condition and operating results or even put us out of business.

Related to Our Product Pipeline

product candidates are still in the early stages of development.

Although we have begun Phase 1a clinical trials for QN-302, we might

be unable to obtain further regulatory approval for QN-302 or any other drug candidate.

We may never obtain marketing approval for any

of our drug candidates.

are still early in our Pan-RAS development efforts and have not yet sought approval for, or begun enrollment, in any clinical trials

evaluating Pan-RAS.

There can be no assurance that any of our drug product candidates will achieve success in their clinical trials or

obtain regulatory approval.

ability to generate revenues from our drug product candidates will depend on the successful development and eventual commercialization

of such drug candidates.

The success of these products will depend on several factors, including the following:

completion of preclinical studies and clinical trials;

of an IND application by the FDA or other clinical trial or similar applications from foreign regulatory authorities for our future

clinical trials for our pipeline;

and successful enrollment of patients in, and completion of, clinical trials with favorable results;

demonstration

of safety, efficacy and acceptable risk-benefit profiles of our products to the satisfaction of the FDA and foreign regulatory agencies;

and related terms of marketing approvals from applicable regulatory authorities, including the completion of any required post-marketing

studies or trials;

and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our products;

and implementing marketing and reimbursement strategies;

sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone

or in collaboration with others;

of our drugs, if and when approved, by patients, the medical community and third-party payors;

competing with other therapies;

and maintaining third-party payor coverage and adequate reimbursement;

a continued acceptable safety profile of the products following approval.

of these factors are beyond our control, and it is possible that none of our drug candidates will ever obtain regulatory approval even

if we expend substantial time and resources seeking such approval.

If we do not achieve one or more of these factors in a timely manner

or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates.

For example, our

business could be harmed if results of the clinical trials of QN-302, Pan-RAS or any other drug candidates vary adversely from our expectations.

development involves a lengthy and expensive process.

We may incur additional costs or experience delays in completing, or ultimately

be unable to complete, the development and commercialization of our drug product candidates.

drug candidates fail, and taking a drug candidate from concept through clinical trials and regulatory approval is not easy or guaranteed.

We are unable to predict when or if our drug candidates, will prove effective or safe in humans or will obtain marketing approval.

obtaining marketing approval from regulatory authorities for the sale of these products, we must complete preclinical development and

then conduct extensive clinical trials to demonstrate the safety and efficacy of these products for humans.

Clinical testing is expensive,

difficult to design and implement, can take many years to complete and is uncertain as to the outcome.

A failure of one or more clinical

trials can occur at any stage of testing.

The outcome of preclinical testing and early clinical trials may not be predictive of the success

of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results.

may experience numerous unforeseen events that could delay or prevent our ability to obtain marketing approval or commercialize our drug

candidates, including:

may not be able to obtain enough capital to begin clinical trials ort to complete any already-begun clinical trials, or to complete

any necessary preclinical studies;

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

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols

with prospective trial sites;

trials for our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to

conduct additional clinical trials, delay clinical trials or abandon product development programs;

number of patients required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical

trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or

the duration of these clinical trials may be longer than we anticipate;

for clinical trial participants from investigational and approved therapies may make it more difficult to enroll patients in our

clinical trials;

third-party contractors may fail to meet their contractual obligations to us in a timely manner, or at all, or may fail to comply

with regulatory requirements;

may have to suspend or terminate clinical trials for our drug candidates for various reasons, including a finding that the participants

are being exposed to unacceptable health risks;

drug candidates may have undesirable or unexpected side effects or other unexpected characteristics, causing us or our investigators,

regulators or IRBs/ECs to suspend or terminate the trials;

cost of clinical trials for our drug candidates may be greater than we anticipate;

supply or quality of our drug candidates, or other materials necessary to conduct clinical trials may be insufficient or inadequate

and result in delays or suspension of our clinical trials.

product development costs will increase if we experience delays in preclinical studies or clinical trials or in obtaining marketing approvals.

We do not know whether any of our planned preclinical studies or clinical trials will begin on a timely basis or at all, will need to

be restructured or will be completed on schedule, or at all.

For example, the FDA may place a partial or full clinical hold on any of

our clinical trials for a variety of reasons.

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

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

our drug candidates.

delays in the commencement or completion, or termination or suspension, of our current clinical trial or our future clinical trials,

if any, could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

we can initiate clinical trials of a drug candidate, we must submit the results of preclinical studies to the FDA along with other information

as part of an IND application or similar regulatory filing, and the FDA (or corresponding foreign regulatory body) must approve the application.

obtaining marketing approval from the FDA for the sale of QN-302, Pan-RAS or any other future drug candidate, we must conduct extensive

clinical studies to demonstrate safety and efficacy.

Clinical testing is expensive, time consuming and uncertain as to outcome.

may require us to conduct additional preclinical studies for any drug candidate before it allows us to initiate clinical trials under

any IND application, which may lead to additional delays and increase the costs of our preclinical development programs.

delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly increase our costs, slow

down our development and approval process and jeopardize our ability to commence product sales and generate revenues.

We do not know

whether our planned trials will begin on time or at all, or be completed on schedule, if at all.

The commencement and completion of clinical

trials can be delayed for a number of reasons, including delays related to:

ability to pay for the costs and expenses for the clinical trials;

FDA disagreeing as to the design or implementation of our clinical trials or with our recommended dose for any of our pipeline programs;

FDA authorization to commence a trial or reaching a consensus with the FDA on trial design;

approval from one or more IRBs/ECs;

refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects,

or withdrawing their approval of the trial;

to clinical trial protocol;

sites deviating from trial protocol or dropping out of a trial;

to manufacture or obtain sufficient quantities of drug candidate, or, if applicable, combination therapies for use in clinical trials;

failing to enroll or remain in our trial at the rate we expect, or failing to return for post-treatment follow-up;

choosing an alternative treatment, or participating in competing clinical trials;

of adequate funding to continue the clinical trial;

experiencing severe or unexpected drug-related adverse effects;

of serious adverse events in trials of the same class of agents conducted by other companies;

or being required to use clinical end points that require prolonged periods of clinical observation or analysis of the resulting

facility manufacturing our drug candidates, or any of their components, including without limitation, our own facilities being ordered

by the FDA to temporarily or permanently shut down due to violations of cGMP, regulations or other applicable requirements, or infections

or cross-contaminations in the manufacturing process;

of stability of our clinical trial material or any quality issues that arise with the clinical trial material;

changes to our manufacturing process that may be necessary or desired;

or our third-party contractors, not performing data collection or analysis in a timely or accurate manner or improperly disclosing

data prematurely or otherwise in violation of a clinical trial protocol;

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities

for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use

some or all of the data produced by such contractors in support of our marketing applications.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials

are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA.

Such authorities may impose such a suspension or

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

our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical

hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using the product under investigation,

changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.

Amendments may require us to resubmit our clinical trial protocols to IRBs/ECs for reexamination, which may impact the costs, timing

or successful completion of a clinical trial.

we experience delays or difficulties enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory

approval could be delayed or prevented.

may not be able to initiate or continue our ongoing or planned clinical trials for our products if we are unable to identify and enroll

a sufficient number of eligible patients to participate in these trials as required by the FDA.

In addition, some of our competitors

may have ongoing clinical trials for products that would treat the same patients as QN-302 or Pan-RAS, and patients who would otherwise

be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ products.

In addition, introduction

of new drugs or devices to the marketplace may have an effect on the number of patients available or timing of the availability of the

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

one or more clinical trials altogether.

side effects or other safety risks associated with our drug product candidates could delay or preclude approval, cause us to suspend

or discontinue any clinical trials or abandon further development, limit the commercial profile of an approved label, or result in significant

negative consequences following regulatory approval, if any.

of our current and planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected

characteristics.

Undesirable side effects caused by our products could result in the delay, suspension or termination of clinical trials

by us or the FDA for a number of reasons.

if our products are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect

to abandon or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics

are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for our

products, if approved.

We may also be required to modify our study plans based on findings in our clinical trials.

Many drug candidates

that initially showed promise in early stage testing have later been found to cause side effects that prevented further development.

In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

is possible that as we test our drug candidates in larger, longer and more extensive clinical trials, including with different dosing

regimens, or as the use of our drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts

and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous

trials, will be reported by patients.

development and commercialization of pharmaceutical and device products are subject to extensive regulation, and we may not obtain regulatory

approvals for any product candidates, on a timely basis or at all.

clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing,

distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other

possible activities relating to drug product candidates such as ours are subject to extensive regulation.

rely, and intend to continue to rely, on third parties to conduct our preclinical studies and clinical trials and perform some of our

research and preclinical studies.

If these third parties do not satisfactorily carry out their contractual duties, fail to comply with

applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased

costs or we may be unable to obtain regulatory approval.

are dependent on third parties to conduct our planned preclinical studies and clinical trials of our drug product candidates.

of the initiation and completion of these trials will therefore be partially controlled by such third parties and may result in delays

to our development programs.

We have relied heavily on UofL for preclinical studies related to Pan-RAS, and we expect to rely heavily

on CROs and sponsored academic researchers for any further preclinical studies.

As to any clinical trials, we expect to rely on CROs,

sponsored academic researchers, clinical investigators and/or consultants to play a significant role in the conduct of these trials and

the subsequent collection and analysis of data.

However, we will not be able to control all aspects of their activities.

Nevertheless,

we are responsible for ensuring that each clinical trial is conducted in accordance with the applicable protocol and legal, regulatory

and scientific standards, including GCP, requirements, and our reliance on the CROs and other third parties does not relieve us of our

regulatory responsibilities.

is no guarantee that any such CROs, clinical trial investigators and/or other third parties on which we rely will devote adequate time

and resources to our development activities or perform as contractually required.

If any of these third parties fail to meet expected

deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate

their engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be

suspended or terminated.

If one of our clinical trial site terminates for any reason, we may experience the loss of follow-up information

on subjects enrolled in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which

may be difficult or impossible.

these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct clinical trials in accordance

with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals

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

Manufacturing

pharmaceutical products is complex and subject to product loss for a variety of reasons.

We contract with third parties for the manufacture

of our product candidates for preclinical testing and clinical trials and expect to continue to do so for commercialization.

This reliance

on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable

cost or quality, which could delay, prevent or impair our development or commercialization efforts.

rely, and expect to continue to rely, on third parties for the manufacture of our products for preclinical and any clinical testing,

as well as for future commercial manufacture if any of our product candidates obtain regulatory approval.

This reliance on third parties

increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or

quality, which could delay, prevent or impair our development or commercialization efforts.

may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms.

Even if we are able to establish

agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

on the third-party for regulatory, compliance and quality assurance;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including

the bankruptcy of the manufacturer or supplier or the issuance of an FDA Form 483 notice or warning letter;

possible breach of the manufacturing agreement by the third-party;

possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us.

do not have manufacturing agreements in place for any of our current drug candidates.

We acquire many key materials on a purchase order

As a result, we do not have long-term committed arrangements with respect to our product candidates and other materials.

obtain regulatory approval for any of our product candidates, we will need to establish an agreement for commercial manufacture with

a third-party.

performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval.

not currently have arrangements in place for redundant supply or a second source for bulk drug substance for QN-302 or Pan-RAS.

will need to seek and enter into out-licenses or collaborations with third parties for the development and commercialization of our products,

resulting in a limitation of our upside potential.

expect that we will need third-party out-licensees or collaborators for the development and commercialization of our products.

likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical

companies and biotechnology companies.

We face significant competition in seeking appropriate collaborators.

Our ability to reach a definitive

agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise,

the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

we do enter into any such arrangements with any third parties, we will likely have limited control over the amount and timing of resources

that such collaborators dedicate to the development or commercialization of our products.

Our ability to generate revenues from these

arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functions assigned to them in

these arrangements.

out-license or collaboration will necessarily result in a sharing of economics with the out licensee or collaborator, which might otherwise

have been captured by us directly.

Related to our Intellectual Property

we are unable to obtain and maintain sufficient patent protection for our therapeutic product candidates, or if the scope of the patent

protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize products similar or identical

to ours, and our ability to commercialize our product candidates successfully may be adversely affected.

commercial success depends significantly on our ability to protect our proprietary (and exclusively in-licensed) product candidates or

technologies that we believe are important to our business, including pursuing, obtaining and maintaining patent protection in the United

States and other countries intended to cover the composition of matter of our product candidates, the methods of use, related technologies,

and other inventions that are important to our business.

In addition to patent protection, we also rely on trade secrets to protect aspects

of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

If we do not adequately pursue,

obtain, maintain, protect or enforce our intellectual property, third parties, including our competitors and/or collaborators, may be

able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

depending on the terms of any license agreements to which we may become a party, we may not have the right to control the preparation,

filing, and prosecution of patent applications, or to maintain or defend the patents, covering technology licensed from third parties.

Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of

our business.

cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents, whether any issued patents will

be found invalid and unenforceable or will be threatened by third parties or whether any issued patents will effectively prevent others

from commercializing competing technologies and product candidates.

Our licensors have not filed patent applications in every jurisdiction,

and some filings are only pending in the United States.

because the issuance of a patent, although presumptive, is not conclusive as to its inventorship, scope, validity or enforceability,

our licensors’ patents or pending patent applications may be challenged in the courts or patent offices in the United States and

Such challenges may result in loss of exclusivity or in the patent claims being narrowed, invalidated or held unenforceable,

in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical products and technologies

or limit the duration of the patent protection of our products and technologies.

Such challenges also may result in substantial cost

and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

licensors’ pending and future patent applications may not result in patents being issued that protect our product candidates and

technologies, in whole or in part, or that effectively prevent others from commercializing competitive products and technologies.

if the patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent

competitors or other third parties from competing with us or otherwise provide us with any competitive advantage.

Our competitors and

other third parties may be able to circumvent our licensors’ patents by developing similar or alternative products or technologies

in a non-infringing manner.

Our competitors and other third parties may also seek approval to market their own products and technologies

similar to or otherwise competitive with our products and technologies.

Alternatively, our competitors or other third parties may seek

to market generic versions of any approved products by submitting abbreviated NDAs to the FDA during which process they may claim that

patents owned by us are invalid, unenforceable or not infringed.

In these circumstances, we may need to defend or assert our licensors’

patents, or both, including by filing lawsuits alleging patent infringement.

In any of these types of proceedings, a court or other agency

with jurisdiction may find our licensors’ patents invalid or unenforceable, or that our competitors are competing in a non-infringing

Thus, even if we have in-licensed valid and enforceable patents, these patents still may not provide protection against competing

products or processes sufficient to achieve our business objectives.

term of our in-licensed patents may be inadequate to protect our competitive position on our products.

the amount of time required for the development, testing and regulatory review of drug candidates, our in-licensed patents protecting

such candidates might expire before or shortly after such candidates are commercialized.

In such an event (and if we are unable to obtain

patent term extension or the term of any such extension is less than we request), our competitors and other third parties may be able

to obtain approval of competing products following patent expiration and take advantage of our investment in development and clinical

trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

Generic competition

usually results in serious price erosion for the original drug brand.

Related to Employee Matters, Potential Dilution, Stock Price Variability and Other Risks Related to Our Business

future success depends on our ability to retain key employees and to attract, retain and motivate qualified personnel.

are highly dependent on Michael Poirier, our Chief Executive Officer and Chairman, and Christopher Lotz, our Vice President and Chief

Financial Officer.

In addition, the rest of our team has been sharply reduced due to rightsizing, voluntary departures and the disposition

of our Qualigen, Inc.

diagnostics-products subsidiary – we currently have only two other employees.

ability to compete depends upon our ability to attract, retain and motivate highly skilled and experienced personnel with scientific,

clinical, regulatory, manufacturing and management skills and experience.

We may not be able to attract or retain qualified personnel

in the future.

Many of the companies against which we compete have greater financial and other resources, different risk profiles and

a longer history in the industry than we do.

Our competitors may provide higher compensation, more diverse opportunities and/or better

opportunities for career advancement.

Any or all of these competing factors (as well as our own limited resources) may limit our ability

to attract and retain high quality personnel, which could negatively affect our ability to successfully develop and commercialize our

product candidates and to grow our business and operations as currently contemplated.

will need to rebuild our development and regulatory teams.

to rightsizing, voluntary departures and the disposition of Qualigen, Inc.

and our former FastPack®products business, we currently

have only four employees .

Although we outsource many drug development functions and may choose to continue to do so in the future, we expect that (resources allowing)

to recruit and retain more employees in all areas, and particularly in the areas of clinical development, clinical operations, and regulatory

affairs (and maybe, longer-term, in areas such as manufacturing, sales, marketing and distribution).

We will also need to implement and

improve our managerial, operational and financial systems, and obtain stage-appropriate facilities.

We do not currently have the cash

resources needed for any of the above.

currently rely, and for the foreseeable future will continue to rely, in substantial part, on certain third-party contract research organizations

and consultants to provide certain services, including assuming substantial responsibilities for the conduct of our clinical trials.

We cannot assure that the services of such third-party contract research organizations and consultants will continue to be available

to us on a timely basis when needed, or that we can find qualified replacements.

In addition, if we are unable to effectively manage

our outsourced activities or if the quality or accuracy of the services provided by our vendors or consultants is compromised for any

reason, our clinical trials may be extended, delayed or terminated.

We cannot assure that we will be able to properly manage our existing

vendors or consultants or find other competent outside vendors and consultants on economically reasonable terms, or at all.

may engage in strategic transactions that could impact liquidity, increase expenses and present significant distractions to management.

time to time, we may consider strategic transactions, such as acquisitions of companies, businesses or assets and out-licensing or in-licensing

of products, drug candidates or technologies.

Potential transactions that we may consider include a variety of different business arrangements,

including spin-offs, in-licensing, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments.

Any such transaction may require us to incur non-recurring or other charges, may increase near term or long-term expenditures and may

pose significant integration challenges or disrupt management or business, which could adversely affect our operations and financial

These transactions may entail

numerous operational and financial risks, including:

to unknown liabilities;

of business and diversion of management’s time and attention in order to develop acquired products, drug candidates or technologies;

of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

than expected acquisition and integration costs;

of assets or impairment charges;

amortization expenses;

and cost in combining the operations, systems and personnel of any acquired businesses with our operations, systems and personnel;

of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;

to retain key employees of any acquired businesses.

minority-interest investment in NanoSynex is illiquid and has many risks associated with it.

investment in NanoSynex has been reduced to a 39% equity interest and has a number of risks associated with it, including, among others,

the following:

history of operating losses, with no assurance of future revenues or operating profits;

as to the availability to NanoSynex of the cash resources it needs to execute its plans;

technological

inability, now that we are no longer a majority shareholder of NanoSynex, to control or veto NanoSynex’s decisions;

associated with the development of medical devices and NanoSynex’s ability to obtain the necessary regulatory approvals for

the development and commercialization of its antimicrobial susceptibility test platform;

limited manufacturing, marketing, distribution and sales capabilities;

from both public and private companies and academic collaborators, many of which have significantly greater experience and financial

by life sciences research and diagnostic communities is not assured;

development of its antimicrobial susceptibility test platform is not assured;

inability to manufacture, market or sell its proposed products if it is unsuccessful in entering into strategic alliances or joint

ventures with third parties;

related to the political, economic and military conditions in Israel.

addition, NanoSynex is a privately-held company and its shares are illiquid, which means that we could not readily obtain cash in exchange

for some or all of our equity interest.

We no longer hold any NanoSynex debt instruments.

reported financial condition may fluctuate significantly from quarter to quarter and year to year, which makes them difficult to predict

or understand.

expect our financial condition and results of operations to fluctuate from quarter to quarter and year to year due to a variety of factors,

many of which are beyond our control.

Accordingly, you should not blindly rely upon the results of any quarterly or annual periods as

indications of future financial status or operating performance.

Other investors may, however, attach undue significance to reported

results which are heavily influenced by such distortions and variability, which in turn could cause our stock price to rise or fall despite

there being no corresponding change in our prospects or position as a practical matter.

have a substantial amount of derivative securities outstanding.

of December 31, 2023 there were 398,924 stock options outstanding under our equity incentive plans, 3,081,717 outstanding warrants, and

1,943,729 shares issuable upon voluntary conversion of principal amount of the 2022 Debenture issued to Alpha.

(At December 31, 2023,

such principal amount was $1,418,922) Due to antidilution adjustments occurring as a result of the 2024 Debenture transaction in February

2024, the outstanding principal balance of the 2022 Debenture (which at March 25, 2024 was $1,088,922) is now convertible upon voluntary

conversions into 4,188,162 shares;

and in addition the 2024 Debenture’s principal amount is convertible upon voluntary conversions

into 900,016 shares, and the warrants issued with the 2024 Debenture are exercisable for 900,016 shares.

2022 and 2024 Debentures issued to Alpha are convertible, at any time, and from time to time, at Alpha’s option, into shares of

our common stock, subject to the terms and conditions described in the Debentures.

Currently the conversion price for such optional conversions

is $0.26 per share for the 2022 Debenture and $0.6111 per share for the 2024 Debenture.

Furthermore, subject to certain terms and conditions

described in the 2022 Debenture, we may elect to pay all or a portion of the Monthly Redemption Amount and/or interest required by the

2022 Debenture in shares of our common stock.

issuance of shares upon the exercise or conversion of outstanding stock options, warrants and the Debentures (or our election to pay

amounts owed under the Debentures in shares of our common stock) could result in significant dilution to the holders of our existing

outstanding common stock.

rely significantly upon information technology, and any failure, inadequacy, interruption or security lapse of that technology, including

any cyber security incidents, could harm our ability to operate our business effectively and result in a material disruption of our product

development programs.

utilize information technology systems to transmit and store information, including sensitive personal information and proprietary or

confidential information, and otherwise to support our business and process.

In the future, our systems may prove inadequate to our business

needs and necessary upgrades may not operate as designed, which could result in excessive costs or disruptions in portions of our business.

In particular, any disruptions, delays or deficiencies from our enterprise resource planning systems could adversely affect our ability

to, among other matters, process orders, procure supplies, manufacture and ship products, send invoices and track payments, fulfill contractual

obligations or otherwise operate our business.

could also be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss

of information maintained in the information systems and networks of our company.

Outside parties may attempt to penetrate our systems

or those of our partners or fraudulently induce our employees or employees of our partners to disclose sensitive information to gain

access to our data.

Like other companies, we may experience threats to our data and systems, including malicious codes and computer viruses,

cyber-attacks or other system failures.

Furthermore, a security breach could be facilitated by ineffective protection measures, employee

errors or omissions, and malfeasance.

Despite our efforts to protect against cyber-attacks and security breaches, hackers and other cyber

criminals are using increasingly sophisticated and constantly evolving techniques, and we may need to expend substantial additional resources

to continue to protect against potential security breaches or to remediate problems caused by such attacks or any breach of our safeguards.

Any system failure, accident or security breach that causes interruptions in our operations, for us or our partners, could result in

a material disruption of our product development programs and business operations, in addition to possibly requiring substantial expenditures

of resources to remedy.

For example, the loss of clinical trial data from completed clinical trials could result in delays in our regulatory

approval efforts and we could incur significant increases in costs to recover or reproduce the data.

cyber incidents could also be increased by cyberwarfare in connection with the ongoing war in Ukraine, including potential proliferation

of malware from the conflict into systems unrelated to the conflict.

To the extent that any disruption or security breach results in

a loss of, or damage to, our data or applications, or inappropriate public disclosure of confidential or proprietary information, we

may incur liabilities and the further development of our product candidates may be delayed.

or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery

plans may not adequately protect us from a serious disaster.

are located in southern California and are subject to risks posed by natural disasters, including wildfires, earthquakes and severe weather

that may interfere with our operations.

Extreme weather events and other natural disasters could severely disrupt our operations, and

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

If a natural disaster, power

outage or other event occurred that damaged critical infrastructure, such as the facilities of our third-party clinical sites or contract

manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business

for a substantial period of time.

Any disaster recovery and business continuity plans we have in place may prove inadequate in the event

of a serious disaster or similar event.

Related to Our Business

factors raise substantial doubt about the Company’s ability to continue as a going concern.

Company has incurred significant losses since its inception, including a net loss of $6.3 million for the year ended December 31, 2024,

and has an accumulated deficit of $123.1 million as of December 31, 2024.

These factors, among others, raise substantial doubt about

the Company’s ability to continue as a going concern.

The Company’s continuation as a going concern is dependent upon its

ability to generate positive cash flows from operations and to secure additional sources of equity and/or debt financing.

Company’s intent to fund operations through equity and debt financing arrangements, there is no assurance that such financing will

be available on terms acceptable to the Company, if at all.

independent auditors have included an explanatory paragraph in their audit report regarding the Company’s ability to continue as

a going concern.

This going concern risk may materially limit our ability to raise additional funds through the issuance of new debt

or equity or may adversely affect the terms upon which such capital may be available.

The inability to obtain sufficient financing on

acceptable terms could have a material adverse effect on the Company’s financial condition, results of operations, and business

Company is actively pursuing strategies to mitigate these risks.

However, there can be no assurance that these efforts will prove successful

or that the Company will achieve its intended financial stability.

The failure to successfully address these going concern risks may

materially and adversely affect the Company’s business, financial condition, and results of operations.

Investors should consider

the substantial risks and uncertainties inherent in the Company’s business before investing in the Company’s securities.

failure to develop or maintain effective internal controls over financial reporting or difficulties encountered in implementing or improving

1 unchanged sentence

internal controls, particularly those related to financial reporting, are necessary for us to produce reliable financial reports.

we cannot provide reliable financial reports, our business and operating results could be harmed, investors could lose confidence in

our reported financial information, and the trading price of our common stock could drop significantly.

In addition, investors relying

upon this misinformation could make an uninformed investment decision, and we could be subject to sanctions or investigations by the

SEC or other regulatory authorities or to stockholder class action securities litigation.

previously described in our annual report on Form 10-K for the year ended December 31, 2021, in connection with the audit of our financial

statements as of and for the year ended December 31, 2021 (the “2021 audit”), our management identified a material weakness in our internal control over financial reporting related to the lack of accounting department

resources and/or policies and procedures to ensure recording and disclosure of items in compliance with U.S.

This material weakness

resulted in adjustments to our warrant valuations in connection with the 2021 audit.

In response to the material weakness, we took a

number of remediation steps to enhance our internal controls, including implementing additional procedures and utilizing external consulting

resources with experience and expertise in U.S.

GAAP and public company accounting and reporting requirements to assist management with

its accounting and reporting of complex and/or non-recurring transactions and related disclosures.

In connection with the audit of our financial statements as of and for the year ended December 31, 2022 (the “2022 audit”),

our management determined that the material weakness identified in connection with the 2021 audit had not been fully remediated

and resulted in adjustments to the accounting treatment related to convertible debt, the business combination and goodwill impairment

during the 2022 audit, which resulted in the late filing of the 2022 Annual Report.

connection with the audit of our financial statements as of and for the year ended December 31, 2023, our management identified material weaknesses in our internal control over financial reporting related to limited accounting

personnel and resources resulting in lack of segregation of duties, and to the fact that we have not designed and implemented effective Information Technology General Controls related

to access controls to financing accounting systems.

intend to continue to take steps to enhance our internal controls, including implementing additional internal procedures and utilizing

well-established external consulting resources with experience and expertise in U.S.

GAAP and public company accounting and reporting

requirements.

we are unable to remediate the material weaknesses and achieve and maintain effective internal control over financial reporting and effective

disclosure controls, our business could be adversely affected.

right to use our “shelf” Form S-3 registration statement is sharply limited.

filed a Form S-3 “shelf” registration statement with the SEC for the issuance of up to $150,000,000 of securities, and the

SEC declared the registration statement effective on August 5, 2022.

However, due to the “baby shelf” rules adopted by the

SEC, the maximum amount of securities we can sell under this registration is now limited to one-third of our public float.

public float is very modest (e.g., $2.9 million at December 31, 2023), the maximum amount we could sell using this registration statement

was under $1.0 million at that time.

Therefore, the registration statement no longer constitutes an important tool for accessing the

public markets to satisfy our needs for capital.

failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

we fail to satisfy the continued listing requirements of Nasdaq, Nasdaq may take steps to delist our common stock.

Such a delisting would

likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when

you wish to do so.

April 20, 2023, we received a notification letter from the Listing Qualifications Department of Nasdaq indicating that, as a result of

our delay in filing the 2022 Annual Report, we were not in compliance with the timely filing requirements for continued listing under

Nasdaq Listing Rule 5250(c)(1).

The notification letter had no immediate effect on the listing or trading of our common stock on the

Nasdaq Capital Market.

On May 2, 2023, the Company filed the Form 10-K with the SEC and was subsequently notified by Nasdaq on May 4,

2023 that it had regained compliance with Nasdaq’s listing rule 5250(c)(1) as a result thereof and that the matter was closed.

November 20, 2023, we received a letter (the “Bid Price Deficiency Notice”) from The Nasdaq Stock Market (“Nasdaq”)

notifying the Company that, because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business

days, it no longer complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

Nasdaq Listing

Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”),

and Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for

a period of 30 consecutive business days.

Bid Price Deficiency Notice has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market.

Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has been provided an initial compliance period of 180 calendar days, or

until May 20, 2024 to regain compliance with the Minimum Bid Price Requirement.

During the compliance period, the Company’s shares

of common stock will continue to be listed and traded on The Nasdaq Capital Market.

To regain compliance, the closing bid price of the

Company’s common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar

day grace period.

the event the Company is not in compliance with the Minimum Bid Price Requirement by May 20, 2024, the Company may be afforded a second

180 calendar day grace period.

Company intends to actively monitor the bid price for its common stock between now and May 20, 2024 and will consider available options

to regain compliance with the Minimum Bid Price Requirement.

November 21, 2023, the Company also received a letter (the “Equity Deficiency Letter”) from Nasdaq notifying the Company

that, based on the Company’s stockholders’ deficit of ($1,640,552) as of September 30, 2023, as reported in the Company’s

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, it is no longer in compliance with the minimum stockholders’

equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1), which requires listed companies

to maintain stockholders’ equity of at least $2.5 million (the “Minimum Stockholders’ Equity Requirement”), or

the alternative criteria of $35 million market value of listed securities or $500,000 in net income from continuing operations in the

most recent fiscal year or two or the last three fiscal years—which alternatives, as noted in the Equity Deficiency Letter, the

Company does not meet.

The Company was given until January 5, 2024 to provide Nasdaq with a specific plan (the “Compliance Plan”)

to achieve and sustain compliance with the Minimum Stockholders’ Equity Requirement or its alternatives.

If the Company’s

Compliance Plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Equity Deficiency Letter for

the Company to evidence compliance.

Company submitted a Compliance Plan to Nasdaq on January 5, 2024 to regain compliance with the Nasdaq Listing Rules.

The Compliance Plan

was accepted by Nasdaq and the Company was granted an extension of up to 180 calendar days from

the date of the Equity Deficiency Letter (i.e., until May 20, 2024) for the Company to evidence compliance.

If the Company does

not regain compliance within the requisite time period, or if the Company fails to satisfy another Nasdaq requirement for continued listing,

Nasdaq could provide notice that the Company’s securities will become subject to delisting, which delisting determination the Company

has the right to appeal.

we are unable to maintain compliance with Nasdaq’s continued listing requirements, and in the event of a delisting, we would take

action to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken

by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent

our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s other

listing requirements.

our Nasdaq other listing would seriously harm us, by undermining our ability to raise capital and decreasing our attractiveness to possible

merger partners.

cannot provide reliable financial reports, our business and operating results could be harmed, investors could lose confidence in our

reported financial information, and the trading price of our common stock could drop significantly.

In addition, investors relying upon

this misinformation could make an uninformed investment decision, and we could be subject to sanctions or investigations by the SEC or

other regulatory authorities or to stockholder class action securities litigation.

In connection

with the audit of our financial statements as of and for the year ended December 31, 2024 (the “2024 audit”), our management

identified a material weakness in our internal control over financial reporting related to the lack of accounting department resources

and/or policies and procedures to ensure recording and disclosure of items in compliance with U.S.

This material weakness resulted

in adjustments to our prepaid expense accounts and recording short term notes receivable net of current expected credit losses in connection

with the 2024 audit.

In response to the material weakness, we took a number of remediation steps to enhance our internal controls, including

implementing additional procedures and utilizing external consulting resources with experience and expertise in U.S.

GAAP and public company

accounting and reporting requirements to assist management with its accounting and reporting of complex and/or non-recurring transactions

and related disclosures.

In connection with

the audit of our financial statements as of and for the year ended December 31, 2024 (the “2024 audit”), our management determined

that the material weakness identified in connection with the 2024 audit had not been fully remediated and resulted in adjustments to

the accounting treatment related to our prepaid expense accounts and recording short term

notes receivable net of current expected credit losses during the 2024 audit, which resulted in the late filing of the 2024 Annual

the year ended December 31, 2024 audit, we identified the lack of sufficient number of personnel within the accounting function to adequately

segregate duties, the Company did not have a designed and implemented effective Information Technology General Controls (“ITGC”)

related to access controls to financial accounting system, and the Company did not have formalized documentation of its processes and

controls that could be evaluated for proper design and implementation.

to continue to take steps to enhance our internal controls, including implementing additional internal procedures and utilizing well-established

external consulting resources with experience and expertise in U.S.

GAAP and public company accounting and reporting requirements.

If we are unable to remediate the material weaknesses and achieve and maintain effective internal control over financial

reporting and effective disclosure controls, our business could be adversely affected.

uncertain economic conditions, including inflation and the risk of a global recession could impair our ability to forecast and may harm

our business, operating results, including our revenue growth and profitability, financial condition and cash flows.

inflation rates have come down substantially from their 2022 highs, the U.S.

economy is still experiencing higher than target inflation

rates, and high levels of inflation persist in many countries around the world.

Historically, we have not experienced significant inflation

risk in our business.

The global economy suffers from slowing growth and elevated interest rates, and many economists are still unsure

whether a global recession may begin in the near future.

If the global economy slows, our business would likely be adversely affected.

business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity or a

natural disaster.

are growing risks related to the security, confidentiality and integrity of personal and corporate information stored and transmitted

electronically due to increasingly diverse and sophisticated threats to networks, systems and data security.

Potential attacks span a

spectrum from attacks by criminal hackers, hacktivists, and nation state or state-sponsored actors, to employee malfeasance and human

or technological error.

the implementation of security measures, our internal computer systems, and those of third parties on which we rely (including our vendors,

contractors and other third-party partners who process information on our behalf or have access to our systems), are vulnerable to damage

from computer viruses, malware, ransomware, phishing attacks and other forms of social engineering, denial-of-service attacks, third

party or employee theft or misuse and other negligent actions, natural disasters, terrorism, war, telecommunication and electrical failures,

cyberattacks or cyber-intrusions over the internet, security incidents, disruptions, attachments to emails, persons inside our organization,

or persons with access to systems inside our organization.

The risk of a security breach or disruption, particularly through cyberattacks

or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number,

intensity and sophistication of attempted attacks and intrusions from around the world have increased.

If such an event were to occur

and cause interruptions in our operations, it could result in a material disruption of our product development programs.

To the extent

that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure

of confidential or proprietary information, we could incur material legal claims (including class claims) and liability, substantial

remediation costs, regulatory enforcement, liability under data protection laws, additional reporting requirements and damage to our

reputation, and the further development of our product lines could be delayed.

future growth may be limited.

ability to achieve our expansion objectives and to manage our growth effectively depends upon a variety of factors, including our ability

to attract and retain skilled employees, to successfully position and market our product candidates when available, to protect our existing

intellectual property, to capitalize on the potential opportunities we are pursuing with third parties and to acquire sufficient funding

whether internally or externally.

To accommodate growth and compete effectively, we will need cash to fund our operations, including

continuing our research and development efforts on our product candidates, develop additional procedures and controls and increase, train,

motivate and manage our workforce.

There is no assurance that our personnel, systems, procedures and controls will be adequate to support

our potential future operations.

will need additional financing in order to grow our business.

time to time, in order to expand operations to meet customer demand, we will need to incur additional capital expenditures.

These capital

expenditures are intended to be funded from third party sources, including the incurring of debt and/or the sale of additional equity

In addition to requiring additional financing to fund capital expenditures, we may require additional financing to fund working

capital, research and development, sales and marketing, general and administrative expenditures and operating losses.

The incurrence

of debt creates additional financial leverage and therefore an increase in the financial risk of our operations.

The sale of additional

equity securities will be dilutive to the interests of current equity holders.

In addition, there can be no assurance that such additional

financing, whether debt or equity, will be available to us or that it will be available on acceptable commercial terms.

Any inability

to secure such additional financing on appropriate terms could have a materially adverse impact on our business, financial condition

and operating results.

conditions, including direct or indirect acts of war or terrorism, could have an adverse effect on our operations and financial results.

operations could be disrupted by geopolitical conditions, political and social instability, acts of war, terrorist activity or other

similar events.

It is not possible to predict the broader consequences of current global conflicts, although such consequences can include

rising geopolitical tensions, rising regional instability, geopolitical shifts, cyberattacks or the disruption of energy exports for

the parties involved, neighboring parties, or supporting parties of these conflicts or their resulting sanctions.

Such consequences could

materially adversely affect global trade, currency exchange rates, regional economies and the global economy.

These situations remain

uncertain, and while it is difficult to predict the impact of any of the foregoing, these conflicts and actions taken in response to

these conflicts could increase our costs, disrupt our supply chain, reduce our sales and earnings, impair our ability to raise additional

capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

are subject to litigation, which could result in significant expenses and negatively impact our business, financial condition, and results

of operations.

January 29, 2025, Lifesci Capital LC (“Lifesci”) filed a lawsuit against us in the United States District Court for the Southern

District of New York, alleging breach of contract and seeking damages in the amount of $503,483.

We believe that no amount is owed to

Lifesci under the agreement at issue and are vigorously defending against the claims.

However, litigation is inherently uncertain and

costly, and we cannot guarantee the outcome.

An adverse result in this or other legal matters could materially impact our business, reputation,

financial condition, and results of operations.

related to regulatory approval

if our development efforts are successful, we may not obtain regulatory approval for any of our product candidates in the United States

or other jurisdictions, which would prevent us from commercializing our product candidates.

Even if we obtain regulatory approval for

our product candidates, any such approval may be subject to limitations, including with respect to the approved indications or patient

populations, which could impair our ability to successfully commercialize our product candidates.

are not permitted to market or promote or sell any of our product candidates before we receive regulatory approval from the FDA or comparable

foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.

Securing marketing

approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for

each therapeutic indication to establish the product candidate’s safety and efficacy for that indication.

Securing marketing approval

also requires the submission of information about the product manufacturing process to, and inspection or remote regulatory assessment

of manufacturing facilities and clinical trial sites by, the regulatory authorities.

If we do not receive approval from the FDA and comparable

foreign regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in the

United States or in other jurisdictions.

If significant delays in obtaining approval for and commercializing our product candidates occur

in any jurisdiction, our business, financial condition, results of operations, stock price and prospects will be materially harmed.

if our product candidates are approved, they may:

be subject to limitations on the

indicated uses or patient populations for which they may be marketed, distribution restrictions, or other conditions of approval;

contain significant safety warnings,

including boxed warnings, contraindications, and precautions;

not be approved with label statements necessary or

desirable for successful commercialization;

contain requirements for costly post-market testing

and surveillance, or other requirements, including the submission of a REMS to monitor the safety or efficacy of the products.

regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.

If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize

our product candidates as expected, and our ability to generate revenue may be materially impaired.

time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years

following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory

In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change

during the course of a product candidate’s clinical development and may vary among jurisdictions and there may be varying interpretations

of data obtained from preclinical studies or clinical trials, any of which may cause delays or limitations in the approval or a decision

not to approve an application.

These regulatory requirements may require us to amend our clinical trial protocols, conduct additional

preclinical studies or clinical trials that may require regulatory or IRB approval, or otherwise cause delays in the approval or rejection

of an application.

Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate

revenue from the particular product candidate, which may materially harm our business, financial condition, results of operations, stock

price and prospects.

we experience delays in obtaining approval, if we fail to obtain approval of a product candidate or if the label for a product candidate

does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate, the commercial

prospects for such product candidate may be harmed and our ability to generate revenues from that product candidate may be materially

in product candidate manufacturing or formulation may result in additional costs or delay.

product candidates are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it

is common that various aspects of the development program, such as manufacturing methods, facilities, equipment and formulation, are

altered along the way in an effort to optimize processes and results.

Any of these changes could cause our product candidates to perform

differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials.

changes may also require additional testing, or notification to, or approval by the FDA or a comparable foreign regulatory authority.

This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of

one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability to

commence product sales and generate revenue.

approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval

has been granted, and we may be subject to substantial fines, penalties, injunctions, or other enforcement actions, including criminal

actions, if we are determined to be promoting the use of our products for unapproved or “off label” uses, resulting in damage

to our reputation and business.

must comply with requirements concerning advertising and promotion for any product candidates for which we obtain marketing approval.

Promotional communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing

review by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys

general, members of Congress, and the public.

When the FDA or comparable foreign regulatory authorities issue regulatory approval for

a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved.

are not able to obtain FDA approval for desired uses or indications for our product candidates, we may not market or promote them for

those indications and uses, referred to as off label uses, and our business, financial condition, results of operations, stock price

and prospects may be materially harmed.

We also must sufficiently substantiate any claims that we make for our products, including claims

comparing our products to other companies’ products, and must abide by the FDA’s strict requirements regarding the content

of promotion and advertising.

physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ

from those tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products

for indications and uses that are not specifically approved by the FDA.

These off label uses are common across medical specialties and

may constitute an appropriate treatment for some patients in varied circumstances.

Regulatory authorities in the United States generally

do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine.

Regulatory authorities

do, however, restrict communications by biopharmaceutical companies concerning off label use.

we are found to have impermissibly promoted any of our product candidates, we may become subject to significant liability and government

The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting

the promotion of off label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions.

The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several

companies from engaging in off label promotion.

The FDA has also requested that companies enter into consent decrees or permanent injunctions

under which specified promotional conduct is changed or curtailed.

the United States, engaging in the impermissible promotion of our products, following approval, for off label uses can also subject us

to false claims and other litigation under federal and state statutes.

These include fraud and abuse and consumer protection laws, which

can lead to civil penalties, and criminal fines and agreements with governmental authorities that materially restrict the manner in which

we promote or distribute therapeutic products and conduct our business.

These restrictions could include corporate integrity agreements

and non- or deferred prosecution agreements and could lead to exclusion from participation in federal and state healthcare programs,

and suspension and debarment from government contracts and refusal of orders under existing government contracts.

These False Claims

Act lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth.

In addition, False Claims

Act lawsuits may expose manufacturers to follow-on claims by private payers based on fraudulent marketing practices.

This growth in litigation

has increased the risk that a biopharmaceutical company will have to defend a false claims action, pay civil penalties, criminal fines

or restitution, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other

federal and state healthcare programs.

If we do not lawfully promote our approved products, if any, we may become subject to such litigation

and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial

condition, results of operations, stock price and prospects.

the United States, the promotion of biopharmaceutical products is subject to additional FDA requirements and restrictions on promotional

If after one or more of our product candidates obtains marketing approval the FDA determines that our promotional activities

violate its regulations and policies pertaining to product promotion, it could request that we modify our promotional materials or subject

us to regulatory or other enforcement actions, including issuance of warning letters or untitled letters, suspension or withdrawal of

an approved product from the market, requests for recalls, payment of civil fines, disgorgement of money, imposition of operating restrictions,

injunctions or criminal prosecution, and other enforcement actions.

Similarly, industry codes in foreign jurisdictions may prohibit companies

from engaging in certain promotional activities and regulatory agencies in various countries may enforce violations of such codes with

civil penalties.

If we become subject to regulatory and enforcement actions our business, financial condition, results of operations,

stock price and prospects will be materially harmed.

if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which

may result in significant additional expense and limit how we manufacture and market our products.

product candidate for which we obtain marketing approval will be subject to extensive and ongoing requirements of and review by the FDA

and comparable foreign regulatory authorities, including requirements related to the manufacturing processes, post approval clinical

data, labeling, packaging, distribution, adverse event reporting, shortage reporting, risk management plans, supply chain security, storage,

recordkeeping, export, import, advertising, marketing, and promotional activities for such product.

These requirements further include

submissions of safety and other post-marketing information, including manufacturing deviations and reports, registration and listing

requirements, the payment of annual fees, continued compliance with current Good Manufacturing Practice, or cGMP, requirements relating

to manufacturing, quality control, quality assurance, and corresponding maintenance of records and documents, and good clinical practices,

or GCPs, for any clinical trials that we conduct post approval.

FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.

If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates,

they may withdraw approval, issue public safety alerts, require labeling changes or establishment of a REMS or similar strategy, impose

significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post

approval studies or post-market surveillance.

Any such restrictions could limit sales of the product.

and any of our suppliers or collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections

or remote regulatory assessments by the FDA to monitor and ensure compliance with cGMPs and other FDA regulatory requirements.

holders must further notify the FDA, and depending on the nature of the change, obtain FDA preapproval for product and manufacturing

addition, later discovery of previously unknown adverse events or that the product is less effective than previously thought or other

problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements both before and

after approval, may yield various negative results, including:

restrictions on manufacturing, distribution,

or marketing of such products;

restrictions on the labeling, including required additional

warnings, such as black boxed warnings, contraindications, precautions, and restrictions on the approved indication or use;

modifications to promotional pieces;

issuance of corrective information;

requirements to conduct post-marketing studies or other

clinical trials;

clinical holds or termination of clinical trials;

requirements to establish or modify a REMS or similar

changes to the way the product candidate is administered;

liability for harm caused to patients or subjects;

reputational harm;

the product becoming less competitive;

warning, untitled, or cyber letters;

suspension of marketing or withdrawal of the products

from the market;

regulatory authority issuance of safety alerts, Dear

Healthcare Provider letters, press releases, or other communications containing warnings or other safety information about the product

refusal to approve pending applications or supplements

to approved applications that we submit;

recalls of products;

fines, restitution or disgorgement of profits or revenues;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of our products;

product seizure or detention;

FDA debarment, suspension and debarment from government

procurement and non-procurement programs, and refusal of orders under existing government contracts, exclusion from federal healthcare

programs, consent decrees, corporate integrity agreements, or non- or deferred prosecution agreements;

injunctions, the imposition of civil penalties, criminal

fines, or imprisonment.

of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, or

could substantially increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating

significant revenues from its marketing and sale.

Any of these events could further have other material and adverse effects on our operations

and business and could adversely impact our business, financial condition, results of operations, stock price and prospects.

FDA’s policies or those of comparable foreign regulatory authorities may change and additional government regulations may be enacted

that could prevent, limit or delay regulatory approval of our product candidates, limit the marketability of our product candidates,

or impose additional regulatory obligations on us.

Changes in medical practice and standard of care may also impact the marketability

of our product candidates.

we are slow or unable to adapt to changes in existing requirements, standards of care, or the adoption of new requirements or policies,

or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject

to regulatory enforcement action.

any of the above actions take place, we could be prevented from or significantly delayed in achieving profitability.

Further, the cost

of compliance with post approval regulations may have a negative effect on our operations and business and could adversely impact our

business, financial condition, results of operations, stock price and prospects.

related to commercialization

face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and

other research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing

them more successfully than us.

If their product candidates are shown to be safer or more effective than ours, our commercial opportunity

may be reduced or eliminated.

development and commercialization of cancer immunotherapy products is characterized by rapidly advancing technologies, intense competition

and a strong emphasis on proprietary rights.

We face competition with respect to our current product candidates, and will face competition

with respect to any product candidates that we may seek to develop or commercialize in the future, from major biopharmaceutical companies,

specialty biopharmaceutical companies, and biotechnology companies worldwide.

There are a number of large biopharmaceutical and biotechnology

companies that currently market and sell products or are pursuing the development of products for the treatment of solid tumors, including

oncolytic immunotherapy and cancer vaccine approaches.

Potential competitors also include academic institutions, government agencies,

and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements

for research, development, manufacturing, and commercialization.

our product candidates are intended to be used in combination with other drugs with different mechanisms of action, if and when marketed

they will still compete with a number of drugs that are currently marketed or in development that also target cancer.

To compete effectively

with these drugs, our product candidates will need to demonstrate advantages in clinical efficacy and safety compared to these competitors

when used alone or in combination with other drugs.

commercial opportunities 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 easier to administer or are less expensive alone or in combination with other therapies than

any products that we may develop alone or in combination with other therapies.

Our competitors also may obtain FDA or comparable foreign

regulatory authority 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 are able to enter the market.

Further, depending on the specific competing product, earlier

approval of a competitor’s products could block us from receiving approval and could require that we change our development strategy.

In addition, our ability to compete may be affected in many cases by insurers or other third-party payors coverage decisions or third-party

intellectual property rights that another may allege are violated by our product candidates.

of the companies with which we are competing or may compete in the future have significantly greater financial resources and expertise

in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing

approved products than we do.

Mergers and acquisitions in the biopharmaceutical and biotechnology industries may result in even more

resources being concentrated among a smaller number of our competitors.

Early stage companies may also prove to be significant competitors,

particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting

and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical

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

If we are unable to successfully

compete with these companies our business, financial condition, results of operations, stock price and prospects may be materially harmed.

we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market

and sell our product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.

and when our product candidates receive marketing approval, we intend to commercialize our product candidates on our own in the United

States and potentially with pharmaceutical or biotechnology partners in other geographies.

In order to commercialize our products, we

must continue to build our marketing, sales, and distribution capabilities or make arrangements with third parties to perform these services,

and we may not be successful in doing so.

We have incurred and we expect we will continue to incur expenses prior to product launch or

even approval in order to recruit a sales force and develop a marketing and sales infrastructure.

If a commercial launch is delayed as

a result of FDA or comparable foreign regulatory authority requirements or other reasons, we would incur these expenses prior to being

able to realize any revenue from sales of our product candidates.

Our sales force and marketing teams may not be successful in commercializing

our product candidates.

This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing

may also or alternatively decide to collaborate with third-party marketing and sales organizations to commercialize any approved product

candidates in the United States, in which event, our ability to generate product revenues may be limited.

To the extent we rely on third

parties to commercialize any products for which we obtain regulatory approval, we may receive less revenues than if we commercialized

these products ourselves, which could materially harm our prospects.

In addition, we would have less control over the sales efforts of

any other third parties involved in our commercialization efforts, and could be held liable if they failed to comply with applicable

legal or regulatory requirements.

have no prior experience in the marketing, sale, and distribution of biopharmaceutical products, and there are significant risks involved

in building, managing, growing and operating a commercial infrastructure.

The establishment and development of commercial capabilities,

including compliance plans, to market any products we may develop is, and will continue to be expensive and time consuming and could

delay any product launch, and we may not be able to successfully develop this capability.

We have and will continue to compete with other

biopharmaceutical and biotechnology companies, including oncology-focused companies, to recruit, hire, train, manage, and retain marketing

and sales personnel, which is expensive and time consuming and could delay any product launch.

Developing our sales capabilities may

also divert resources and management attention away from product development.

the event we are unable to develop an effective marketing and sales infrastructure, we may not be able to commercialize our product candidates

in the United States or elsewhere in an effective manner, which could limit our ability to generate product revenues and materially harm

our business, financial condition, results of operations, stock price and prospects.

Factors that may inhibit our efforts to commercialize

our product candidates include:

the inability to recruit, train,

manage, and retain adequate numbers of effective sales and marketing personnel;

the inability of sales personnel to obtain access to

physicians or persuade adequate numbers of physicians to prescribe our product candidates;

our inability to effectively oversee

a geographically dispersed sales and marketing team;

the costs associated with training sales and marketing

personnel on legal and regulatory compliance matters and monitoring their actions;

an inability to secure adequate coverage and reimbursement

by government and private health plans;

the clinical indications for which the products are

approved and the claims that we may make for the products;

limitations or warnings, including distribution or

use restrictions, contained in the products’ approved labeling;

any distribution and use restrictions imposed by the

FDA or comparable foreign regulatory authorities or to which we agree as part of a mandatory REMS or voluntary risk management plan;

third-party intellectual property rights that another

may allege are violated by our product candidates;

liability for sales or marketing personnel who fail

to comply with the applicable legal and regulatory requirements;

the lack of complementary products to be offered by

sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

unforeseen costs and expenses associated with creating

an independent sales and marketing organization or engaging a contract sales organization.

we continue to evolve from a company primarily involved in research and development to a company also expected to be involved in commercialization,

we may encounter difficulties in managing our growth and expanding our operations successfully.

anticipate that, as our operations expand and, assuming that our development, testing, studies and trials are successful, we will need

to expand our internal manufacturing, marketing and sales capabilities.

Managing our future growth will impose significant added responsibilities

on members of our management team and will be time consuming and costly.

We must be able to manage our development efforts effectively;

manage our clinical trials effectively;

hire, train and integrate additional management, development, administrative and sales and marketing

and improve managerial, development, operational and finance systems, all of which may impose a strain on our administrative

and operational infrastructure.

product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of

product candidate development.

can be no assurance that any development problems we experience in the future will not cause significant delays or unanticipated costs,

or that such development problems can be solved.

Should we encounter development problems, including unfavorable preclinical or clinical

trial results, the FDA and foreign regulatory authorities may refuse to approve our product candidates, or may require additional information,

tests, or trials, which could significantly delay product development and significantly increase our development costs.

Moreover, even

if we are able to provide the requested information or trials to the FDA, there would be no guarantee that the FDA would accept them

or approve our product candidates.

We may also experience delays in developing a sustainable, reproducible and scalable manufacturing

process, or developing or qualifying and validating product release assays, other testing and manufacturing methods, and our equipment

and facilities in a timely manner, which may prevent us from completing our clinical trials or commercializing our product candidates

on a timely or profitable basis, if at all.

addition, the clinical trial requirements of the FDA and comparable foreign regulatory authorities and the criteria these regulators

use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended

use and market of the potential products.

The FDA and comparable foreign regulatory authorities have limited experience with the approval

of oncolytic immunotherapies.

Limited immunotherapies have received FDA approval to date.

Any product candidates that are approved may

be subject to extensive post approval regulatory requirements, including requirements pertaining to manufacturing, distribution, and

We may need to devote significant time and resources to compliance with these requirements.

our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we

may never become profitable.

have never commercialized a product candidate for any indication.

Even if our product candidates are approved by the appropriate regulatory

authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical

If any product candidates for which we obtain regulatory approval do not gain an adequate level of market acceptance, we could

be prevented from or significantly delayed in achieving profitability.

Additionally,

efforts to educate the medical community and third party payors on the benefits of our product candidates may require significant resources

and may not be successful.

If any of our product candidates is approved but does not achieve an adequate level of market acceptance,

we could be prevented from or significantly delayed in achieving profitability.

degree of market acceptance of any of our product candidates will depend on a number of factors, some of which are out of our control,

including the following:

the efficacy of our product

candidates in combination with marketed checkpoint blockade drugs;

the commercial success of the checkpoint blockade

drugs with which our products are co-administered;

the prevalence and severity of adverse events

associated with our product candidates or those products with which they are co-administered;

the clinical indications for which the products

are approved and the approved claims that we may make for the products;

limitations or warnings contained in the product’s

FDA-approved labeling or those of comparable foreign regulatory authorities, including potential limitations or warnings for our

product candidates that may be more restrictive than other competitive products;

changes in the standard of care for the targeted

indications for our product candidates, which could reduce the marketing impact of any claims that we could make following FDA approval

or approval by comparable foreign regulatory authorities, if obtained;

the relative convenience and ease of administration

of our product candidates by direct injection into tumors, a less common method for the administration of oncology therapies than

systemic administration, which may result in slower adoption of our therapies;

the relative convenience and ease of administration

of any products with which our product candidates are co-administered;

the cost of treatment compared with the economic

and clinical benefit of alternative treatments or therapies;

the availability of adequate coverage or reimbursement

by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare

and Medicaid;

the price concessions required by third party

payors to obtain coverage;

the extent and strength of our marketing and

distribution of our product candidates;

the safety, efficacy, and other potential

advantages over, and availability of, alternative treatments already used or that may later be approved;

distribution and use restrictions imposed

by the FDA or comparable foreign regulatory authorities with respect to our product candidates or to which we agree as part of a

REMS or voluntary risk management plan;

the timing of market introduction of our product

candidates, as well as competitive products;

our ability to offer our product candidates

for sale at competitive prices;

the willingness of the target patient population

to try new therapies and of physicians to prescribe these therapies;

the extent and strength of our manufacturing

operations and our third-party manufacturer and supplier support;

the actions of companies that market any products

with which our product candidates are co-administered;

the approval of other new products;

adverse publicity about our product candidates

or any products with which they are co-administered, or favorable publicity about competitive products;

potential product liability claims.

successful commercialization of our product candidates, if approved, will depend in part on the extent to which government authorities

and health insurers establish adequate reimbursement levels and pricing policies.

of any approved drug candidate will depend in part on the availability of coverage and reimbursement from third-party payers such as

government insurance programs, including, but not limited to, Medicare and Medicaid, private health insurers, health maintenance organizations

and other health care related organizations, who are increasingly challenging the price of medical products and services.

coverage and reimbursement may be uncertain.

Adoption of any drug by the medical community may be limited if third-party payers will

not offer adequate formulary coverage.

Additionally, significant uncertainty exists as to the reimbursement status of newly-approved

Cost control initiatives may decrease coverage and payment levels for any drug and, in turn, the price that we will be able to

charge and/or the volume of our sales.

We are unable to predict all changes to the coverage or reimbursement methodologies that will

be applied by private or government payers.

Any denial of private or government payer coverage or inadequate reimbursement could harm

our business and reduce our revenue.

addition, both the federal and state governments in the United States and foreign governments continue to propose and pass new legislation,

regulations, and policies affecting coverage and reimbursement rates, which are designed to contain or reduce the cost of health care.

Further federal and state proposals and healthcare reforms are likely, which could limit the prices that can be charged for the product

candidates that we develop and may further limit our commercial opportunity.

For example, the Inflation Reduction Act of 2022, or IRA,

includes several measures intended to lower the cost of prescription drugs and related healthcare reforms, including limits on price

increases, inflation and non-compliance penalties, and subjecting an escalating number of drugs to annual maximum fair price negotiations

We cannot be sure whether additional legislation related to the IRA will be issued or enacted, or what impact, if any, such

changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

There also may be

future changes unrelated to the IRA that result in reductions in potential coverage and reimbursement levels for our product candidates,

if approved and commercialized, and we cannot predict the scope of any future changes or the impact that those changes would have on

our operations.

Similarly, several states have established prescription drug affordability boards that set upper payment limits (maximum

prices that can be charged for specific drugs) for select high-cost drugs.

We cannot be sure whether additional state legislation related

to price caps will be enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if

approved for commercial use, in the future.

future reimbursement for approved product candidates, if any, is substantially less than we project, or rebate and/or discount, or fees

and obligations associated with them are substantially greater than we expect, our future net revenue and profitability could be materially

size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual

markets for our product candidates may be smaller than our estimates.

potential market opportunities for our product candidates are difficult to estimate and will depend in large part on the drugs with which

our product candidates are co-administered and the success of competing therapies and therapeutic approaches.

Our estimates of the potential

market opportunities are predicated on many assumptions, which may include industry knowledge and publications, third-party research

reports, and surveys of clinics.

Although we believe that our internal assumptions are reasonable, these assumptions involve the exercise

of significant judgment on the part of our management, are inherently uncertain, and their reasonableness has not been assessed by an

independent source.

If any of the assumptions proves to be inaccurate, the actual markets for our product candidates could be smaller

than our estimates of the potential market opportunities.

Related to the Ownership of Our Securities

have a large number of authorized but unissued shares of our common stock which will dilute existing ownership positions when issued.

December 31, 2024, our authorized capital stock consists of 225 million shares of common stock, of which approximately 224.3 million

remain available for issuance, including shares of common stock issuable upon the exercise of outstanding derivative securities.

management will continue to have broad discretion to issue shares of our common stock in a range of transactions, including capital-raising

transactions, mergers, acquisitions and other transactions, without obtaining stockholder approval, unless stockholder approval is required

under law or the rules of Nasdaq or any other trading market on which our common stock may be listed.

If our management determines it

be appropriate to issue shares of our common stock from the large pool of authorized but unissued shares for any purpose in the future

and is not required to obtain stockholder approval, your ownership position would be diluted without your further ability to vote on

that transaction.

common stock may be affected by limited trading volume and price fluctuations, which could adversely impact the value of our common stock.

common stock has experienced, and is likely to experience in the future, significant price and volume fluctuations, which could adversely

affect the market prices of our common stock without regard to our operating performance.

In addition, we believe that factors such as

quarterly fluctuations in our financial results and changes in the overall economy or the condition of the financial markets could cause

the market prices of our common stock and warrants to fluctuate substantially.

These fluctuations may also cause short sellers to periodically

enter the market in the belief that we will have poor results in the future.

We cannot predict the actions of market participants and,

therefore, can offer no assurances that the market for our common stock and warrants will be stable or appreciate over time.

may need, but be unable, to obtain additional funding on satisfactory terms, which could dilute our stockholders or impose burdensome

financial restrictions on our business.

have relied upon cash from financing activities, and, in the future, we hope to rely on revenues generated from operations to fund the

cash requirements of our activities.

However, there can be no assurance that we will be able to generate any significant cash from our

operating activities in the future.

Future financing may not be available on a timely basis, in sufficient amounts or on terms acceptable

to us, if at all.

Any debt financing or other financing of securities senior to the common stock will likely include financial and other

covenants that will restrict our financing and/or operational flexibility.

Any failure to comply with these covenants would have a material

adverse effect on our business, prospects, financial condition and results of operations because we could lose our existing sources of

funding, and our ability to secure new sources of funding could be impaired.

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