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Item 1A. Risk Factors

2025-03-25 compared with 2024-03-29 · 249 added, 266 removed, 1205 unchanged (30% of the section changed)

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pre-clinical and clinical trials of our product candidates;

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

technologies;

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;

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;

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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 $17,509,791 as of December 31, 2023, plus the net proceeds

of $15.5 million from our February 2024 offering of common stock, 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.

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

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.

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:

● successfully

complete development activities, including the necessary clinical trials;

and submit either BLAs or NDAs to the FDA and obtain U.S.

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

regulatory approval for indications

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regulatory approval in territories with viable market sizes;

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

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

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;

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tax attributes to offset its post-change income may be limited.

uncertainty may affect our access to capital and/or increase the costs of such capital.

economic conditions continue to be volatile and uncertain due to, among other things, consumer confidence in future economic conditions,

fears of recession and trade wars, the price of energy, fluctuating interest rates, the availability and cost of consumer credit, the

availability and timing of government stimulus programs, levels of unemployment, increased inflation, tax rates, and the war between

Ukraine and Russia which began in February 2022, and Israel and Hamas, which began in October 2023 and which threatens to spread to other

Middle Eastern countries.

These conditions remain unpredictable and create uncertainties about our ability to raise capital in the future.

In the event required capital becomes unavailable in the future, or more costly, it could have a material adverse effect on our business,

future results of operations, and financial condition.

pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry,

and as a result, our operations and prospects.

January 2025, a memo issued by the Office of Management and Budget, had disclosed a freeze on federal loans and grants.

That memo has

since been rescinded;

however, future memos, executive orders or other actions by the government, including the new Trump Administration,

could result in the freeze of existing or new grants, or the termination of previously approved grants.

Such actions could have a material

adverse effect on the pharmaceutical industry as a whole, a portion of which relies on governmental grants, and as a result, on the Company’s

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.

Relating to the Development and Regulatory Approval of Our Product Candidates

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the following:

● successfully

completing formulation and process development activities;

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marketing approval from applicable regulatory authorities;

● establishing

commercial manufacturing capabilities;

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including, but not limited to:

● discussions

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;

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;

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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 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;

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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;

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;

● termination

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

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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.

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.

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:

● eligibility

criteria of our ongoing and planned clinical trials with specific characteristics appropriate

for inclusion in our clinical trials;

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;

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;

● willingness

of physicians to participate in our planned clinical trials;

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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;

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;

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incur significant additional expenses.

Although in January

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

2024, we do not own or operate any operating manufacturing

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.

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

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 candidates;

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

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’

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.

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:

● limitations

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;

● limitations

in the approved clinical indications for our product candidates;

● demonstrated

clinical safety and efficacy compared to other products;

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marketing and distribution support;

● availability

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

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cost-effectiveness of our product candidates;

● availability

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

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;

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;

● convenience

and ease of administration of our products;

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

● restrictions

on the marketing or manufacturing of the product;

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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;

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;

● injunctions

or the imposition of civil or criminal penalties.

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of clinical trial participants;

● termination

of clinical trial sites or entire trial programs;

regulatory scrutiny;

● significant

litigation costs;

● substantial

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

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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

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;

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.

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.

§ 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.

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.

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

We compete in an industry that

is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition, (iv) new product introductions

and (v) an emphasis on proprietary and novel products and product candidates.

Our competitors, some of which include larger pharmaceutical

companies, biotechnology companies, and academic institutions, have and may develop products and technologies that will compete with our

products and technologies.

Specifically, we face competition from companies developing therapies for AL amyloidosis which include Prothena

Corp, Caelum Biosciences (Now Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

In addition, we face competition from companies

developing cell therapies for autoimmune indications, some of which include Kyverna Therapeutics, Inc.;

compete in an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition,

(iv) new product introductions and (v) an emphasis on proprietary and novel products and product candidates.

Our competitors, some of

which include larger pharmaceutical companies, biotechnology companies, and academic institutions, have and may develop products and

technologies that will compete with our products and technologies.

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,

Cabaletta Bio, Inc.;

Fate Therapeutics

Fate Therapeutics Inc.;

and Arcellx, Inc.

Moreover, companies with approved therapies for blood disorders include, but are not limited to, Novartis AG,

Bristol Myers Squibb Co, and Janssen/Johnson & Johnson.

We also compete with these organizations to recruit management, scientists

and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business plan.

We will also face competition in establishing clinical trial sites, enrolling subjects for clinical trials and in identifying new product

Moreover, companies with approved therapies for blood disorders

include, but are not limited to, Novartis AG, Bristol Myers Squibb Co, and Janssen/Johnson & Johnson.

We also compete with these

organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of expertise

and our ability to execute our business plan.

We will also face competition in establishing clinical trial sites, enrolling subjects

for clinical trials and in identifying new product candidates.

believe that a significant number of products are currently under development, and may become commercially available in the future, for

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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;

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;

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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

granted patents that we rely upon may be held invalid or unenforceable as a result of legal

challenges by third parties;

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.

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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 agreement;

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.

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.

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

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which in turn could materially adversely affect our business, financial condition or results of operations.

may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from

may infringe on the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from

commercializing or increase the costs of commercializing our product candidates.

success will depend in part on our ability to operate without infringing the proprietary rights of third parties.

success will depend in part on our ability to operate without infringing on the proprietary rights of third parties.

We cannot guarantee

that our product candidates, or manufacture or use of our product candidates, will not infringe third-party patents.

Furthermore, a third

party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging

in our normal operations and activities, including making or selling our product candidates.

These lawsuits are costly and could affect

our results of operations and divert the attention of managerial and scientific personnel.

Some of these third parties may be better

capitalized and have more resources than us.

There is a risk that a court would decide that we are infringing the third party’s

patents and would order us to stop the activities covered by the patents.

In that event, we may not have a viable way around the patent

and may need to halt commercialization of our product candidates.

In addition, there is a risk that a court will order us to pay the

other party damages for having violated the other party’s patents.

The pharmaceutical and biotechnology industries have produced

a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products

or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

that our product candidates, or manufacture or use of our product candidates, will not infringe on third-party patents.

a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us

from engaging in our normal operations and activities, including making or selling our product candidates.

These lawsuits are costly

and could affect our results of operations and divert the attention of managerial and scientific personnel.

Some of these third parties

may be better capitalized and have more resources than us.

There is a risk that a court would decide that we are infringing on the third

party’s patents and would order us to stop the activities covered by the patents.

In that event, we may not have a viable way around

the patent and may need to halt commercialization of our product candidates.

In addition, there is a risk that a court will order us

to pay the other party damages for having violated the other party’s patents.

The pharmaceutical and biotechnology industries have

produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types

of products or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not always

we are sued for patent infringement, we would need to demonstrate that our product candidates or methods either do not infringe the patent

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

● publications

in the scientific literature often lag behind actual discoveries.

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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

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.

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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to patent law, including the Leahy-Smith America Invests Act, AIA or Leahy-Smith Act, of 2011 and the Patent Reform Act of 2009 and other

future article of legislation, may substantially change the regulations and procedures surrounding patent applications, issuance of patents,

and prosecution of patents.

future articles of legislation, may substantially change the regulations and procedures surrounding patent applications, issuance of

patents, and prosecution of patents.

We can give no assurances that our patents can be defended or will protect us against future intellectual

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and limitations in trading volumes of our shares of common stock;

ability to obtain financing to conduct and complete research and development activities including,

but not limited to, our clinical trials, and other business activities;

delays in the expected recognition of revenue due to lengthy and sometimes unpredictable

sales timelines;

timing and success of introductions of new products by us or our competitors or any other

change in the competitive dynamics of our industry, including consolidation among competitors,

customers or strategic partners;

ability to obtain financing to conduct and complete research and development activities including, but not limited to, our clinical

trials, and other business activities;

delays in the expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our

industry, including consolidation among competitors, customers or strategic partners;

outages or security breaches;

ability to attract new customers;

ability to secure resources and the necessary personnel to conduct clinical trials on our

desired schedule;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement,

enrollment or results of our clinical trials for our product candidates or any future clinical

trials we may conduct;

enrollment or results of our clinical trials for our product candidates or any future clinical trials we may conduct;

in the development status of our product candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA

or other regulatory agencies’ review of our planned pre-clinical and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions,

including failure to receive regulatory approval for our product candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA or other regulatory agencies’ review

of our planned pre-clinical and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our product candidates;

unanticipated

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inability to enter into new markets or develop new products;

● reputational

● competition

from existing technologies and products or new technologies and products that may emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments,

or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we

conduct our business;

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

and litigation related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

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even if unsuccessful, could be costly to defend and a distraction to management.

are currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock exchange,

our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and

it may be more difficult for our stockholders to sell their securities.

common stock is currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any

stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could

be impaired and it may be more difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum

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requiring stockholder approval.

of March 25, 2024, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially

own approximately 39% 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:

of March 11, 2025, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately

40% 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:

deferring or preventing a change in corporate control;

a merger, consolidation, takeover or other business combination involving us;

● discouraging

a potential acquirer from making a tender offer or otherwise attempting to obtain control

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

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as applicable, among other things:

the board of directors with the ability to alter our Amended and Restated Bylaws without

stockholder approval;

the board of directors with the ability to alter our Amended and Restated Bylaws without stockholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the board of directors or for

proposing matters that can be acted upon at stockholder meetings;

that vacancies on the board of directors may be filled by a majority of directors in office,

although less than a quorum.

advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon

at stockholder meetings;

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 the us or our directors, officers or employees.

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.

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, 2023 as, 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 journal entry processing and review, to allow for a detailed review of accounting transactions that would identify

errors in a timely manner.

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.

have implemented additional review procedures including addition of accounting consultants to remediate such weakness.

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

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(ii) the last day of our fiscal year following the fifth anniversary

of the date of the completion of our initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible

debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the

of the date of the completion of our initial public offering (i.e., December 31, 2026);

(iii) the date on which we have issued more than

$1 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated

filer under the rules of the SEC.

may be at risk of securities class action litigation.

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litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our

business and results in a decline in the market price of our common stock.

business and result in a decline in the market price of our common stock.

reporting obligations of being a public company in the U.S.

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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