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Item 1A. Risk Factors

2026-03-25 compared with 2025-03-25 · 564 added, 308 removed, 1146 unchanged (43% of the section changed)

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of your investment.

References to past events are provided by way of example only and are not intended to be a complete listing or a

representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.

Relating to Our Financial Position and Capital Needs

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for the foreseeable future.

are a clinical-stage biopharmaceutical company focused on developing a novel class of TSTx in oncology and inflammation.

Investment in

biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant

are a clinical-stage biopharmaceutical company focused on the application of CAR-T in AL Amyloidosis and other serious diseases.

in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant

risk that a product candidate will fail to prove effective, gain regulatory approval or become commercially viable.

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As a result, we have not been profitable and have incurred significant operating losses since our inception.

For the years ended December 31, 2024 and 2023, we reported net losses of $21,698,363 and $15,595,522, respectively.

For the years ended December 31, 2025 and 2024, we reported net losses of $29.4 million and $21.7 million, respectively.

As of December

2024, we had an accumulated deficit of $75,024,671.

31, 2025, we had an accumulated deficit of $104.5 million.

do not expect to generate revenues for many years, if at all.

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Our expenses will further increase as we:

pre-clinical and clinical trials of our product candidates;

or acquire the rights to, and pursue development of, other products, product candidates or technologies;

additional clinical, manufacturing, quality control, quality assurance and scientific personnel;

marketing approval for any product candidates that successfully complete clinical trials;

sales, marketing and distribution capabilities, if we receive, or expect to receive, marketing approval for any product candidates;

expand and protect our intellectual property portfolio;

operational, financial and management information systems and personnel.

conduct pre-clinical and

clinical trials of our product candidates;

in-license or acquire the

rights to, and pursue development of, other products, product candidates or technologies;

hire additional clinical,

manufacturing, quality control, quality assurance and scientific personnel;

seek marketing approval

for any product candidates that successfully complete clinical trials;

establish sales, marketing

and distribution capabilities, if we receive, or expect to receive, marketing approval for any product candidates;

maintain, expand and protect

our intellectual property portfolio;

add operational, financial

and management information systems and personnel.

need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of

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programs or commercialization efforts.

will need to raise significant additional capital to complete development and obtain regulatory approval for our product candidates.

Although we believe that our existing cash and cash equivalents balance of $17,681,954 as of December 31, 2024, expected disbursements

under the CIRM grant and expected payments of tax receivables, will be sufficient to meet our cash, operational and liquidity requirements

the funds received in our recent public and private financings, we will need to raise significant additional capital to complete development

and obtain regulatory approval for our product candidates.

Although we believe that our existing cash, cash equivalents and short-term

investments balance of $100.4 million as of December 31, 2025, will be sufficient to meet our cash, operational and liquidity requirements

for at least 12 months from the date of this report, our operating plan may change as a result of many factors currently unknown to us,

and we may need additional funds sooner than planned.

Additionally, we expect that our cash on hand and cash from the CIRM grant will

not be sufficient to complete development and obtain regulatory approval for our product candidates, and we will need to raise significant

additional capital to help us do so.

Additionally, we expect that our cash on hand will not be sufficient to complete

development and obtain regulatory approval for our product candidates, and we will need to raise significant additional capital to help

expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our product

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and achieve profitability also depends on a number of additional factors, including our ability to:

complete development activities, including the necessary clinical trials;

and submit either BLAs or New Drug Application (“NDA”) to the FDA and obtain U.S.

regulatory approval for indications

for which there is a commercial market;

and submit applications to foreign regulatory authorities;

regulatory approval in territories with viable market sizes;

coverage and adequate reimbursement from third parties, including government and private payors;

commercially viable prices for our products, if any;

and maintain supply and manufacturing relationships with reliable third parties, legally globally compliant manufacturing of bulk

drug substances and drug products to maintain that supply;

distribution processes for our product candidates;

commercial quantities of our product candidates, if approved, at acceptable cost levels;

additional funding if required to develop and commercialize our product candidates;

sales, marketing and distribution capabilities for products we intend to sell;

market acceptance of our products;

hire and retain qualified personnel;

our intellectual property rights.

successfully complete development

activities, including the necessary clinical trials;

complete and submit either

BLAs or New Drug Application (“NDA”) to the FDA and obtain U.S.

regulatory approval for indications for which there is

a commercial market;

complete and submit applications

to foreign regulatory authorities;

obtain regulatory approval

in territories with viable market sizes;

obtain coverage and adequate

reimbursement from third parties, including government and private payors;

set commercially viable

prices for our products, if any;

establish and maintain

supply and manufacturing relationships with reliable third parties, legally globally compliant manufacturing of bulk drug substances

and drug products to maintain that supply;

develop distribution processes

for our product candidates;

develop commercial quantities

of our product candidates, if approved, at acceptable cost levels;

obtain additional funding

if required to develop and commercialize our product candidates;

develop sales, marketing

and distribution capabilities for products we intend to sell;

achieve market acceptance

of our products;

attract, hire and retain

qualified personnel;

protect our intellectual

property rights.

revenues for any product candidates for which regulatory approval is obtained will be dependent, in part, upon the size of the markets

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ability to use net operating losses to offset future taxable income may be subject to limitations.

of December 31, 2024 we had federal net operating loss (“NOLs”) carryforwards of approximately $19,850,000.

of December 31, 2025 we had federal net operating loss (“NOLs”) carryforwards of approximately $52.5 million.

Our NOLs generated

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operations and prospects.

may not receive the remaining $4.4 million of the $8 million which we learned was granted to us by the California Institute for

Regenerative Medicine.

July 25, 2024, the Company learned that it was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM)

to support the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s

clinical trials.

Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions

of the grant, CIRM may suspend or permanently cease disbursements.

Funds received under this grant may only be used for allowable project

costs specifically identified with the CIRM-funded project.

Such costs can include, but are not limited to, salary for personnel, itemized

supplies, consultants, and itemized clinical study costs.

Under the terms of the grant, both CIRM and the Company will co-fund the research

project and the amount of the Company’s co-funding requirement is predetermined as a part of the award.

The Company signed the

grant agreement in November 2024 and began receiving funds from the grant in November of 2024.

As of March 11, 2025, the Company has

received $3.6 million in grant reimbursements under the grant agreement.

The Company may not receive the remaining funds on a timely

basis, or at all.

The Company is required to complete certain requirements and agree to certain terms and conditions in connection with

such grant, which have not been completed in full as of the date of this Report.

In the event the remaining funds were not received on

a timely basis, or at all, or subject to conditions, the Company could be forced to seek out alternative funding.

shutdown of the U.S.

federal government may adversely affect our business.

recurring shutdown of the U.S.

federal government may adversely affect our business operations.

During such shutdowns, while the SEC’s

EDGAR system remains operational, the unavailability of the SEC staff to review filings, issue and resolve comments, or declare registration

statements effective may delay our ability to complete public offerings and obtain timely regulatory approvals.

These delays could impact

our access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations.

Additionally,

the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks.

There can be no assurance

that future shutdowns will not materially affect our operations or financial condition.

funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’

staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services

from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions

on which the operation of our business may rely, which could negatively impact our business.

business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings,

and oversight of clinical trials.

Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel

cuts, policy changes and those related to the federal government shutdown, may result in reduced staffing or suspension of non-essential

FDA operations, which could delay or cancel meetings with the FDA, hinder regulatory guidance, cause delays in the implementation or

enforcement of regulatory requirements in a timely fashion or at all, and postpone the review of IND applications, New Drug Applications

(NDAs), and Biologics License Applications (BLAs).

These disruptions may also affect the initiation, conduct, and monitoring of clinical

trials, particularly those requiring FDA authorization or ongoing regulatory engagement.

Interruptions in FDA activities could materially

delay our development timelines, increase operational costs, and adversely impact our ability to complete our ongoing and planned clinical

trials and to advance product candidates toward approval and commercialization.

Any such delays or uncertainties may have a significant

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

may apply for government grants to support some of our research and development activities for our product candidates.

A lapse in appropriations

resulting in a government shutdown could materially disrupt the timing and availability of these funds.

During such shutdowns, federal

agencies may suspend the processing of new grant applications, delay reimbursements, or pause disbursements for existing awards.

interruptions could adversely affect our ability to complete our planned research and development activities.

federal government should have another shutdown or if the FDA, National Institutes of Health (“NIH”), SEC or the

United States Patent and Trademark Office (“USPTO”) experiences significant decreases in funding or personnel, it could significantly

impact the ability of the FDA to issue licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants,

and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse

effect on our business.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary

capital in order to properly capitalize and continue our operations.

is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of

the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.

Additionally,

the new administration could also issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or

create a more challenging or costly environment to pursue the development of new therapeutic candidates.

may not receive the remaining $1.8 million of the $8 million which we learned was granted to us by the California Institute for Regenerative

July 25, 2024, we learned that we were awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to

support the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

The award is payable to us upon achievement of milestones that are primarily based on patient enrollment in our clinical trials.

Additionally,

if CIRM determines, in its sole discretion, that we have not complied with the terms and conditions of the grant, CIRM may suspend or

permanently cease disbursements.

Funds received under this grant may only be used for allowable project costs specifically identified

with the CIRM-funded project.

Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and

itemized clinical study costs.

Under the terms of the grant, both CIRM and the Company will co-fund the research project and the amount

of our co-funding requirement is predetermined as a part of the award.

We signed the grant agreement in November 2024 and began receiving

funds from the grant in November of 2024.

As of March 20, 2026, we have received $6.2 million in grant reimbursements under the grant

The Company may not receive the remaining funds on a timely basis, or at all.

We are required to complete certain requirements

and agree to certain terms and conditions in connection with such grant, which have not been completed in full as of the date of this

Annual Report on Form 10-K.

In the event the remaining funds were not received on a timely basis, or at all, or subject to conditions,

we could be forced to seek out alternative funding.

Relating to the Development and Regulatory Approval of Our Product Candidates

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the following:

completing formulation and process development activities;

clinical trials that demonstrate the efficacy and safety of our product candidates;

marketing approval from applicable regulatory authorities;

commercial manufacturing capabilities;

commercial sales, marketing and distribution operations.

successfully completing

formulation and process development activities;

completing clinical trials

that demonstrate the efficacy and safety of our product candidates;

receiving marketing approval

from applicable regulatory authorities;

establishing commercial

manufacturing capabilities;

launching commercial sales,

marketing and distribution operations.

of these factors are wholly or partially beyond our control, including clinical advancement, the regulatory submission process and changes

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including, but not limited to:

with the FDA or other regulatory agencies regarding the scope or design of our clinical trials;

limited number of, and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other

clinical trial programs, including some that may be for the same indication as our product candidates;

delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned;

to obtain sufficient funds required for a clinical trial;

holds on, or other regulatory objections to, a new or ongoing clinical trial;

or failure to manufacture sufficient supplies of product candidates for our clinical trials;

or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or

clinical research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly

among different sites or CROs;

or failure to obtain IRB approval to conduct a clinical trial at a prospective site;

than expected rates of patient recruitment and enrollment;

of patients to complete the clinical trial;

inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant

treatment effects;

safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths;

of efficacy during clinical trials;

of our clinical trials by one or more clinical trial sites;

or unwillingness of patients or clinical investigators to follow our clinical trial protocols;

to monitor patients adequately during or after treatment;

study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at

all, deviating from the protocol or dropping out of a study;

to address any non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;

need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

clinical trials may be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason

by, current or future strategic partners that have responsibility for the clinical development of any of our product candidates.

discussions with the FDA

or other regulatory agencies regarding the scope or design of our clinical trials;

the limited number of,

and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other clinical trial

programs, including some that may be for the same indication as our product candidates;

any delay or failure to

obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned;

inability to obtain sufficient

funds required for a clinical trial;

clinical holds on, or other

regulatory objections to, a new or ongoing clinical trial;

delay or failure to manufacture

sufficient supplies of product candidates for our clinical trials;

delay or failure to reach

agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or clinical research organizations

(“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly among different sites

delay or failure to obtain

IRB approval to conduct a clinical trial at a prospective site;

slower than expected rates

of patient recruitment and enrollment;

failure of patients to

complete the clinical trial;

the inability to enroll

a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects;

unforeseen safety issues,

including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths;

lack of efficacy during

clinical trials;

termination of our clinical

trials by one or more clinical trial sites;

inability or unwillingness

of patients or clinical investigators to follow our clinical trial protocols;

inability to monitor patients

adequately during or after treatment;

clinical study sites failing

to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from

the protocol or dropping out of a study;

inability to address any

non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;

the need to repeat or terminate

clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

our clinical trials may

be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future

strategic partners that have responsibility for the clinical development of any of our product candidates.

in regulatory requirements, policies and guidelines may also occur and we may need to significantly amend clinical trial protocols to

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factors may affect our ability to identify, enroll and maintain qualified patients, including the following:

criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;

of the clinical trial;

and nature of the patient population;

perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in

relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

availability and efficacy of competing therapies and clinical trials;

of other trials underway in the same patient population;

of physicians to participate in our planned clinical trials;

of the disease under investigation;

of patients to clinical sites;

who do not complete the trials for personal reasons;

with CROs and/or with other vendors that handle our clinical trials.

eligibility criteria of

our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;

design of the clinical

size and nature of the

patient population;

patients’ perceptions

as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to

other available therapies, including any new drugs that may be approved for the indications we are investigating;

the availability and efficacy

of competing therapies and clinical trials;

pendency of other trials

underway in the same patient population;

willingness of physicians

to participate in our planned clinical trials;

severity of the disease

under investigation;

proximity of patients to

clinical sites;

patients who do not complete

the trials for personal reasons;

issues with CROs and/or

with other vendors that handle our clinical trials.

may not be able to initiate or continue to support clinical trials of our product candidates for one or more indications, or any future

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any such determination that any of our product candidates are safe or effective for use by the general public for any indication.

of our product candidates are still in pre-clinical or early clinical development.

of our product candidates are still in pre-clinical or clinical development.

Additionally, all of our product candidates are required

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by such products:

authorities may require us to take our approved product off the market;

authorities may require the addition of labeling statements, specific warnings, and/or a contraindication or field alerts to physicians

and pharmacies;

may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

may be subject to limitations on how we may promote the product;

of the product may decrease significantly;

may be subject to litigation or product liability claims;

reputation may suffer.

regulatory authorities

may require us to take our approved product off the market;

regulatory authorities

may require the addition of labeling statements, specific warnings, and/or a contraindication or field alerts to physicians and pharmacies;

we may be required to change

the way the product is administered, conduct additional clinical trials or change the labeling of the product;

we may be subject to limitations

on how we may promote the product;

sales of the product may

decrease significantly;

we may be subject to litigation

or product liability claims;

our reputation may suffer.

of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase

commercialization costs and expenses, which in turn could delay or prevent us from generating revenue from the sale of any future products.

general, CAR-T cell therapy has historically been associated with serious toxicities.

general, CAR-T cell therapy is associated with serious toxicities that contribute to morbidity and mortality.

These include serious life-threatening

adverse events, such as cytopenia, infections, grade 3 and grade 4 CRS, and neurologic toxicity.

Given the deep responses achieved in

patients with hematologic malignancies treated with CAR-T and the crucial unmet need in relapsed/refractory AL amyloidosis for such deep

hematologic responses, NXC-201 therapy appears promising.

However, safety remains a significant concern, considering the frailty of AL

are dependent on third parties for manufacturing and marketing of our product candidates.

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incur significant additional expenses.

in January 2024, the Company entered into a long-term operating lease agreement for manufacturing space located in California, and as

of March 11, 2025, we do not own or operate any FDA approved operating manufacturing facilities.

We rely on and intend to continue to

rely on CMOs to formulate and manufacture our pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks,

any of which could delay or prevent the completion of our pre-clinical studies or clinical trials, or the regulatory approval or commercialization

in January 2024, we entered into a long-term operating lease agreement for manufacturing space located in California, and as of March

20, 2026, we do not own or operate any FDA approved operating manufacturing facilities.

We rely on and intend to continue to rely on CMOs

to formulate and manufacture our pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks, any of which

could delay or prevent the completion of our pre-clinical studies or clinical trials, or the regulatory approval or commercialization

of our product candidates, result in higher costs, or deprive us of potential product revenues.

Some of these risks include:

CMO failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product

CMO failing to manufacture our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise

manufacturing material that we, the FDA or other regulatory agencies may deem to be unsuitable in our clinical trials;

CMO being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience

a shortage in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of

our product candidates.

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale,

or we will be able to find alternative manufacturers acceptable to us that can do so;

CMO placing a priority on the manufacture of their own products, or other customers’ products;

CMO failing to perform as agreed upon or not remain in business;

CMO’s plants being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

our CMO failing to develop

an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates;

our CMO failing to manufacture

our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise manufacturing material that

we, the FDA or other regulatory agencies may deem to be unsuitable in our clinical trials;

our CMO being unable to

increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience a shortage

in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of our product

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale, or we will

be able to find alternative manufacturers acceptable to us that can do so;

our CMO placing a priority

on the manufacture of their own products, or other customers’ products;

our CMO failing to perform

as agreed upon or not remain in business;

our CMO’s plants

being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

Manufacturers

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The degree of market acceptance of our product candidates will depend on a number of factors, including:

or warnings contained in the approved labeling for a product candidate;

in the standard of care for the targeted indications for any of our product candidates;

in the approved clinical indications for our product candidates;

clinical safety and efficacy compared to other products;

of significant adverse side effects;

marketing and distribution support;

of coverage and reimbursement amounts from managed care plans and other third-party payors;

of market introduction and perceived effectiveness of competitive products;

cost-effectiveness of our product candidates;

of alternative products at similar or lower cost, including generic and over-the-counter products;

extent to which the product candidate is approved for inclusion on formularies of hospitals and managed care organizations;

the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for

particular diseases;

the product can be used effectively with other therapies to achieve higher response rates;

publicity about our product candidates or favorable publicity about competitive products;

and ease of administration of our products;

product liability claims.

limitations or warnings

contained in the approved labeling for a product candidate;

changes in the standard

of care for the targeted indications for any of our product candidates;

limitations in the approved

clinical indications for our product candidates;

demonstrated clinical safety

and efficacy compared to other products;

lack of significant adverse

side effects;

sales, marketing and distribution

availability of coverage

and reimbursement amounts from managed care plans and other third-party payors;

timing of market introduction

and perceived effectiveness of competitive products;

the cost-effectiveness

of our product candidates;

availability of alternative

products at similar or lower cost, including generic and over-the-counter products;

the extent to which the

product candidate is approved for inclusion on formularies of hospitals and managed care organizations;

whether the product is

designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular diseases;

whether the product can

be used effectively with other therapies to achieve higher response rates;

adverse publicity about

our product candidates or favorable publicity about competitive products;

convenience and ease of

administration of our products;

potential product liability

any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, patients and the medical

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manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

on the marketing or manufacturing of the product;

of the product from the market or voluntary or mandatory product recalls;

warning letters or holds on clinical trials;

by the FDA, European Medicines Agency (“EMA”) or another competent regulatory authority to approve pending applications

or supplements to approved applications filed by us, or suspension or revocation of product license approvals;

seizure or detention, or refusal to permit the import or export of products;

or the imposition of civil or criminal penalties.

restrictions on the marketing

or manufacturing of the product;

withdrawal of the product

from the market or voluntary or mandatory product recalls;

fines, warning letters

or holds on clinical trials;

refusal by the FDA, European

Medicines Agency (“EMA”) or another competent regulatory authority to approve pending applications or supplements to

approved applications filed by us, or suspension or revocation of product license approvals;

product seizure or detention,

or refusal to permit the import or export of products;

injunctions or the imposition

of civil or criminal penalties.

of any of the foregoing could have a material and adverse effect on our business and results of operations.

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

demand for any future approved products;

to our reputation;

of clinical trial participants;

of clinical trial sites or entire trial programs;

regulatory scrutiny;

litigation costs;

monetary awards to or costly settlement with patients or other claimants;

recalls or a change in the indications for which products may be used;

of management and scientific resources from our business operations;

inability to commercialize our product candidates.

decreased demand for any

future approved products;

injury to our reputation;

withdrawal of clinical

trial participants;

termination of clinical

trial sites or entire trial programs;

increased regulatory scrutiny;

significant litigation

substantial monetary awards

to or costly settlement with patients or other claimants;

product recalls or a change

in the indications for which products may be used;

loss of revenue;

diversion of management

and scientific resources from our business operations;

the inability to commercialize

our product candidates.

any of our product candidates are approved for commercial sale, we will be highly dependent upon consumer perceptions of us and the safety

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laws to which we will be subject and which could impact our business activities include the following.

and state healthcare program anti-kickback laws (including the federal Anti-Kickback Statute and Civil Monetary Penalties Law) prohibit

among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral

of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under

federal healthcare programs such as the Medicare and Medicaid programs.

Such anti-kickback laws can be implicated by, among other

activities, marketing arrangements with ordering providers, discount or rebate programs or other inducements to purchase our products.

Violation of these laws can result in criminal prosecution and imposition of criminal penalties and fines, as well civil monetary

penalties and multiple damage judgments, and exclusion from participation in federal healthcare programs;

Omnibus Budget Reconciliation Act of 1993 (42 U.S.C.

§ 1395nn) prohibit referrals by ordering by a physician of “designated

health services” which include pharmaceuticals and drugs that are payable, in whole or in part, by Medicare or Medicaid, to

an entity in which the physician or the physician’s immediate family member has an investment interest or other financial relationship,

subject to several exceptions.

Financial relationships that are implicated by the Stark Law can include arrangements ranging from

marketing arrangements and consulting agreements to medical director agreements with physicians who order our products.

Law also prohibits billing for services rendered pursuant to a prohibited referral.

Several states have enacted laws similar to the

These state laws may cover all (not just Medicare and Medicaid) patients.

If we violate the Stark Law, our financial results

and operations could be adversely affected.

Penalties for violations include denial of payment for the services, significant civil

monetary penalties, and exclusion from the Medicare and Medicaid programs;

false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented,

claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities

like us which provide coding and billing information to customers;

which imposes certain requirements relating to the privacy, security and transmission of protected health information which includes

individually identifiable health information, demographic data, medical histories and test results;

Federal Food, Drug and Cosmetic Act which among other things, strictly regulates drug manufacturing and product marketing, prohibits

manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

Physician Payments Sunshine Act which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment

is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually

to the CMS, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists,

podiatrists, and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and

teaching hospitals, and ownership and investment interests held by physicians and their immediate family members and applicable group

purchasing organizations;

law equivalents of each of the above federal laws, such as, Stark Law, anti-kickback and false claims laws which may apply to items

or services reimbursed by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies

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

by the federal government, state laws that require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers, marketing expenditures, or drug pricing, state and local laws that require

the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information

in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus

complicating compliance efforts.

federal and state healthcare

program anti-kickback laws (including the federal Anti-Kickback Statute and Civil Monetary Penalties Law) prohibit among other things,

persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual,

for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare

programs such as the Medicare and Medicaid programs.

Such anti-kickback laws can be implicated by, among other activities, marketing

arrangements with ordering providers, discount or rebate programs or other inducements to purchase our products.

Violation of these

laws can result in criminal prosecution and imposition of criminal penalties and fines, as well civil monetary penalties and multiple

damage judgments, and exclusion from participation in federal healthcare programs;

the Omnibus Budget Reconciliation

Act of 1993 (42 U.S.C.

§ 1395nn) prohibit referrals by ordering by a physician of “designated health services” which

include pharmaceuticals and drugs that are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician

or the physician’s immediate family member has an investment interest or other financial relationship, subject to several exceptions.

Financial relationships that are implicated by the Stark Law can include arrangements ranging from marketing arrangements and consulting

agreements to medical director agreements with physicians who order our products.

The Stark Law also prohibits billing for services

rendered pursuant to a prohibited referral.

Several states have enacted laws similar to the Stark Law.

These state laws may cover

all (not just Medicare and Medicaid) patients.

If we violate the Stark Law, our financial results and operations could be adversely

Penalties for violations include denial of payment for the services, significant civil monetary penalties, and exclusion

from the Medicare and Medicaid programs;

federal false claims laws

which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment

from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which

provide coding and billing information to customers;

HIPAA which imposes certain

requirements relating to the privacy, security and transmission of protected health information which includes individually identifiable

health information, demographic data, medical histories and test results;

the Federal Food, Drug

and Cosmetic Act which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from

marketing drug products for off-label use and regulates the distribution of drug samples;

The Physician Payments

Sunshine Act which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under

Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS, information

related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists,

and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals,

and ownership and investment interests held by physicians and their immediate family members and applicable group purchasing organizations;

state law equivalents of

each of the above federal laws, such as, Stark Law, anti-kickback and false claims laws which may apply to items or services reimbursed

by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical

industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state

laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other

healthcare providers, marketing expenditures, or drug pricing, state and local laws that require the registration of pharmaceutical

sales representatives, and state laws governing the privacy and security of health information in certain circumstances, many of

which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we may

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we have limited financial and managerial resources, we intend to prioritize our efforts on specific research and development programs,

including clinical development of NXC-201, IMX-110, IMX-111 and IMX-120 or other future product candidates.

As a result, we may forgo

or delay pursuit of other opportunities, including with potential future product candidates that later prove to have greater commercial

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

Our spending on current and future research and development programs and product candidates for specific indications may not yield any

commercially viable drug candidates.

If we do not accurately evaluate the commercial potential or target market for a particular product

candidate, we may relinquish valuable rights to that product candidate through partnership, licensing or other royalty arrangements in

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

including clinical development of NXC-201 and IMX-110 or other future product candidates.

As a result, we may forgo or delay pursuit

of other opportunities, including with potential future product candidates that later prove to have greater commercial potential.

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

spending on current and future research and development programs and product candidates for specific indications may not yield any commercially

viable drug candidates.

If we do not accurately evaluate the commercial potential or target market for a particular product candidate,

we may relinquish valuable rights to that product candidate through partnership, licensing or other royalty arrangements in cases in

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

the market opportunities for our current and potential future product candidates are smaller than we believe they are, our ability to

generate product revenue may be adversely affected and our business may suffer.

understanding of the number of people who suffer from certain types of cancers, hematologic malignancies and inflammatory diseases as

well as ulcerative colitis and Crohn’s disease that our product candidates may have the potential to treat is based on estimates.

These estimates may prove to be incorrect, and new studies may demonstrate or suggest a lower estimated incidence or prevalence of such

The number of patients in the United States or elsewhere may turn out to be lower than expected, may not be otherwise amenable

to treatment with our current or potential future product candidates or patients may become increasingly difficult to identify and access,

all of which would adversely affect our business prospects and financial condition.

understanding of the number of people who suffer from certain types of cancers, hematologic malignancies and inflammatory diseases that

our product candidates may have the potential to treat is based on estimates.

These estimates may prove to be incorrect, and new studies

may demonstrate or suggest a lower estimated incidence or prevalence of such diseases.

The number of patients in the United States or

elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our current or potential future product

candidates or patients may become increasingly difficult to identify and access, all of which would adversely affect our business prospects

and financial condition.

products will face significant competition, and if they are unable to compete successfully, our business will suffer.

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Specifically, we face competition from companies developing therapies

for AL amyloidosis which include Prothena Corp, Caelum Biosciences (Now Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

we face competition from companies developing cell therapies for immune-mediated disease, some of which include Kyverna Therapeutics,

for AL amyloidosis which include Prothena Corp, Caelum Biosciences (n/k/a Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

addition, we face competition from companies developing cell therapies for immune-mediated disease, some of which include Kyverna Therapeutics,

Cabaletta Bio, Inc.;

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effect on our business.

of artificial intelligence in research, development, and commercial activities presents operational, regulatory, ethical, and reputational

risks that could adversely affect our business.

increasingly rely on artificial intelligence (“AI”) and machine-learning systems across our research, development, clinical,

manufacturing, and commercial operations.

These tools support activities such as target identification, compound screening, biomarker

discovery, clinical-trial design and recruitment, pharmacovigilance monitoring, supply-chain optimization, and commercial analytics.

Because AI models—particularly those applied to biological and clinical datasets—can behave unpredictably or produce biased

or inaccurate outputs, our reliance on such systems may expose us to operational and scientific risks.

Any errors or limitations in AI-generated

insights could delay discovery efforts, impair the design or execution of our clinical trials, misinform safety or efficacy assessments,

or otherwise negatively impact the advancement of our pipeline candidates.

regulatory environment applicable to AI remains highly uncertain and continues to evolve in the United States and globally.

have begun scrutinizing AI applications in healthcare and life sciences, and we may face new obligations related to transparency, data

provenance, model documentation, validation standards, or auditability.

In particular, new or forthcoming requirements from U.S.

agencies and international authorities could impose additional burdens on our R&D workflows or clinical-trial operations, limiting

how we design studies, analyze endpoints, select patient populations, or interact with clinical investigators and regulatory bodies.

As noted by recent legal and regulatory commentary, public companies must carefully assess and disclose material AI-related risks, and

the SEC has emphasized that inaccurate or overstated claims about AI capabilities—commonly referred to as “AI-washing”—may

give rise to enforcement actions and shareholder litigation.

Any failure to provide accurate AI-related disclosures could subject us

to reputational damage, regulatory proceedings, or securities claims.

use of AI may also introduce data-integrity and cybersecurity risks.

AI systems used in drug development frequently involve sensitive

clinical, genomic, or proprietary datasets, making them potential targets for data-poisoning attacks, model manipulation, or unauthorized

Compromised AI tools could corrupt datasets, distort model outputs related to safety or efficacy, or expose confidential patient

or trial information.

Additionally, reliance on third-party AI vendors, cloud providers, or specialized platforms—some outside

traditional pharmaceutical quality-system regulations—may increase our exposure to operational disruptions, confidentiality breaches,

or compliance failures.

also face competitive risks.

AI-enabled research continues to transform discovery timelines, trial execution, and manufacturing processes

within the biopharmaceutical industry.

If competitors adopt more advanced AI systems, access higher-quality proprietary datasets, or

integrate AI more efficiently into R&D or commercial processes, we may be placed at a competitive disadvantage.

Conversely, over-reliance

on emerging AI technologies that ultimately do not perform as expected could divert resources, impair strategic decision-making, or delay

program progression.

AI technologies and regulatory expectations evolve, we may incur significant additional costs to update systems, retrain personnel, validate

models, modify documentation, or enhance governance and oversight.

If we fail to appropriately manage these risks, our research productivity,

clinical development timelines, regulatory interactions, commercial performance, financial condition, or reputation could be materially

adversely affected.

geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations.

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and global economies, the United States and global financial markets and

adverse geopolitical and macroeconomic developments, including rising inflation rates, the continuing impact of the COVID-19 pandemic,

the Ukrainian/Russian and Israeli/Palestinian conflicts and related sanctions, bank failures, and economic uncertainties related to these

adverse geopolitical and macroeconomic developments, including rising inflation rates, the impact of pandemics, the Ukrainian/Russian

and Israeli/Palestinian conflicts and related sanctions, bank failures, and economic uncertainties related to these conditions.

example, inflation rates, particularly in the United States, have increased recently to levels not seen in years, and increased inflation

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government programs, including Medicare and Medicaid, integrity oversight and reporting obligations, or reputational harm.

climate-disclosure laws may impose significant compliance burdens, create operational disruptions, and divert resources critical to the

advancement of our clinical programs.

has enacted two unprecedented climate-disclosure laws—SB-253 (Climate Corporate Data Accountability Act) and SB-261 (Climate-Related

Financial Risk Act)—that apply to companies “doing business” in California meeting specified revenue thresholds.

requires companies with over $1 billion in annual revenue to report Scope 1 and 2 greenhouse-gas (“GHG”) emissions beginning

in 2026, and Scope 3 emissions beginning in 2027, while SB-261 requires biennial climate-risk disclosures from companies with over $500

million in revenue, with initial statutory deadlines in 2026.

Although enforcement timing for SB-261’s initial deadline has been

temporarily affected by a Ninth Circuit injunction, companies are still expected to prepare for forthcoming compliance once the appeal

a clinical-stage biopharmaceutical company, we rely heavily on complex clinical-trial networks, third-party contract research organizations

(“CROs”), clinical sites, laboratories, and manufacturers.

Preparing emission disclosures—especially Scope 3 value-chain

emissions, which include activities across our clinical and supply-chain ecosystem—may require gathering extensive data from external

partners that do not currently track GHG emissions at the level of detail mandated by California’s regulations.

CARB guidance emphasizes

that accurate disclosures often take three to six months to compile, and companies should begin preparations well in advance of the 2026

These requirements may present outsized challenges for companies like ours that lack large internal compliance infrastructures.

addition, SB-261 requires companies to identify climate-related physical and transition risks—such as wildfire exposure, climate-related

supply-chain disruptions, and regulatory changes—which may directly affect our clinical operations, particularly if investigative

sites, manufacturing partners, or logistics providers are located in regions exposed to climate-driven events.

Complying with these emerging

obligations may require the implementation of new data-collection systems, climate-risk assessment frameworks, governance structures,

and potentially third-party assurance services.

These activities could divert financial and human resources away from our core R&D

priorities, including ongoing and planned clinical trials.

regulators have further signaled that non-compliance may result in penalties and that “good-faith efforts” may be expected

even for companies facing data-collection challenges in early reporting years.

Because we are pre-commercial and do not generate product

revenue, any expansion of compliance costs—including costs associated with emissions modeling, environmental consultants, and reporting

assurance—could materially impact our operating expenses and extend our cash runway requirements.

the regulatory landscape remains fluid.

CARB continues to refine regulatory definitions, deadlines, and enforcement expectations, and

ongoing litigation creates uncertainty regarding the ultimate scope and timing of compliance requirements.

New guidance or amendments

could require material changes to our reporting processes or climate-risk governance practices, resulting in additional operating costs

we fail to comply timely or accurately with California’s climate-disclosure laws, or if our disclosures highlight material climate-related

risks related to our clinical operations, we could face regulatory scrutiny, reputational harm, or litigation.

Any of these outcomes

could have a material adverse effect on our business, results of operations, and ability to advance our clinical development programs.

Relating to our Intellectual Property

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protect our rights or permit us to gain or keep our competitive advantage.

may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our patents;

might not have been the first to make the inventions covered by our pending patent applications;

might not have been the first to file patent applications for these inventions;

pending patent applications may not result in issued patents;

claims of our issued patents or patent applications when issued may not cover our products or product candidates;

patents that we may obtain from licensing or otherwise may not provide us with any competitive advantages;

granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

patents of others may have an adverse effect on our business.

others may be able to make

compounds that are similar to our product candidates, but that are not covered by the claims of our patents;

we might not have been

the first to make the inventions covered by our pending patent applications;

we might not have been

the first to file patent applications for these inventions;

our pending patent applications

may not result in issued patents;

the claims of our issued

patents or patent applications when issued may not cover our products or product candidates;

any patents that we may

obtain from licensing or otherwise may not provide us with any competitive advantages;

any granted patents that

we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

the patents of others may

have an adverse effect on our business.

we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or

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addition, disputes may arise regarding intellectual property subject to a license agreement, including:

scope of rights granted under the license agreement and other interpretation-related issues;

extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing

diligence obligations under the license agreement and what activities satisfy those obligations;

a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements,

we may be required to sublicense rights in that area to a third party, and that sublicense could harm our business;

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

the scope of rights granted

under the license agreement and other interpretation-related issues;

the extent to which our

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

our diligence obligations

under the license agreement and what activities satisfy those obligations;

if a third-party expresses

interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required

to sublicense rights in that area to a third party, and that sublicense could harm our business;

the ownership of inventions

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

disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements

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first to invent the technology, because:

patent applications in the U.S.

some patent applications

may be maintained in secrecy until the patents are issued;

applications in the U.S.

patent applications in

are typically not published until 18 months after the priority date;

in the scientific literature often lag behind actual discoveries.

publications in the scientific

literature often lag behind actual discoveries.

competitors may have filed, and may in the future file, patent applications covering products and technology similar to ours.

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do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:

monetary damages related to the legal expenses of the third party;

additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial

condition, and the commercial viability of our products;

restructuring

our Company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical

trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

paying monetary damages

related to the legal expenses of the third party;

facing additional competition

that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the

commercial viability of our products;

restructuring our Company

or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial,

and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

third party may also challenge the validity, enforceability or scope of the intellectual property rights that we own or in the future

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approval in any jurisdiction.

may seek a Breakthrough Therapy Designation for some of our product candidates.

A breakthrough therapy is defined as a therapy that is

intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and

preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more

clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

For therapies that have

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

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

designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval.

Designation as a breakthrough

therapy is within the discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets the criteria for designation

as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event, the receipt of a Breakthrough

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

considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

In addition, even if one

or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer

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

have been granted Breakthrough Therapy designation by the FDA to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory

AL amyloidosis and we may seek a Breakthrough Therapy designation for additional indications or some of other or future product candidates.

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

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

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

in clinical development.

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

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

patients placed in ineffective control regimens.

Therapies designated as breakthrough therapies by the FDA may also be eligible for priority

review and accelerated approval.

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

Accordingly, even if we believe

one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine

not to make such designation.

In any event, the receipt of a Breakthrough Therapy designation for a product candidate may not result

in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and

does not assure ultimate approval by the FDA.

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

the FDA may later decide that such product candidates no longer meet the conditions for qualification or decide that the time period

for FDA review or approval will not be shortened.

may seek Fast Track designation for some of our product candidates for therapeutic indications.

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review vouchers.

Drug Designation does not translate to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other

expected benefits.

we have been granted orphan drug designation for NXC-201, this does not mean FDA will approve the BLA.

Even if we obtain FDA approval,

we may not be able to obtain or maintain orphan drug exclusivity for NXC-201.

We may not be the first to obtain marketing approval of

NXC-201 for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products.

exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated

indication or may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to

assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Further, even if we obtain

orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs

with different active moieties may be approved for the same condition, or the competitive product is otherwise outside the scope of exclusivity.

Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition

if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution

to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity.

drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory

review or approval process, nor does it prevent competitors from obtaining approval of the same product candidate for indications other

than those in which orphan drug designation have been granted.

Related to Owning our Common Stock

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46.8% of our outstanding shares of common stock.

As a result, these stockholders, acting together, would have the ability to control the

outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale

of all or substantially all of our assets.

In addition, these stockholders, acting together, would have the ability to control the management

and affairs of our Company.

Accordingly, this concentration of ownership might harm the market price of our common stock by:

As a result, these stockholders, acting together, would have the ability to control

the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation

or sale of all or substantially all of our assets.

In addition, these stockholders, acting together, would have the ability to control

the management and affairs of our Company.

Accordingly, this concentration of ownership might harm the market price of our common stock

deferring or preventing a change in corporate control;

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that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially

all disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for

disputes with us or our directors, officers or employees.

Amended and Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive

forum for substantially all disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable

judicial forum for disputes with us or our directors, officers or employees.

Amended and Restated Certificate of Incorporation provides that unless we consent in writing to the selection of an alternative forum,

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costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial

to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our

common stock.

If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner.

Our management

concluded there was a material weakness in our internal control over financial reporting as of December 31, 2024, due to our small size,

and our limited number of personnel, we did not have in place an effective internal control environment with formal processes and procedures,

including adequate segregation of duties within systems.

A material weakness is a significant deficiency, or a combination of significant

deficiencies, in internal control over financial reporting such that it is reasonably possible that a material misstatement of the annual

or interim financial statements will not be prevented or detected on a timely basis.

We have implemented remediation

steps in 2025 which have strengthened our internal controls, including:

addition of personnel with significant relevant experience in public company internal control

environments;

of a reputable third-party expert to assist with enhancing our risk assessment and control testing process;

● establishment

of addition points of segregation of duties;

● improvement

of our financial close process;

to our information technology general controls.

While we believe

that our remediation efforts will resolve the identified material weakness, there is no assurance that such efforts will be sufficient

or that additional actions will not be necessary, which may undermine our ability to provide accurate, timely and reliable reports on

our financial and operating results.

Furthermore, if we remediate our current material weakness but identify new material weaknesses

in our internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our

financial reports and the market price of our common stock may be negatively affected.

As a result of such failures, we could also become

subject to investigations by Nasdaq, the SEC, or other regulatory authorities, and become subject to litigation from investors and stockholders,

which could harm our reputation, financial condition or divert financial and management resources from our business.

and economic conditions may negatively impact our business, financial condition and share price.

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growth companies, which could make our common stock less attractive to investors.

In addition, as a smaller reporting company we will

also have reduced disclosure requirements.

are an “emerging growth company,” as defined in the JOBS Act and we intend to take advantage of certain exemptions from various

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filer under the rules of the SEC.

are also a “smaller reporting company” as defined in the Securities Exchange Act, and have elected to take advantage of certain

of the scaled disclosures available to smaller reporting companies.

To the extent that we continue to qualify as a “smaller reporting

company” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company,

certain of the exemptions available to us as an “emerging growth company” may continue to be available to us as a “smaller

reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to the Sarbanes-Oxley

Act of 2002 and reduced disclosure about our executive compensation arrangements.

We will continue to be a “smaller reporting company”

until we have $250 million or more in public float (based on our common stock) measured as of the last business day of our most recently

completed second fiscal quarter or, in the event we have no public float (based on our common stock) or a public float (based on our

common stock) that is less than $700 million, annual revenues of $100 million or more during the most recently completed fiscal year.

may be at risk of securities class action litigation.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors