What changed in this filing

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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-10 · 217 added, 146 removed, 1393 unchanged (21% of the section changed)

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company as we:

the requirements and demands of being a public company;

our operational, financial and management systems and increase personnel to support our operations;

additional clinical, quality control, medical, scientific and other technical personnel to support our clinical operations;

our clinical-stage product candidate PF614 through clinical development;

our preclinical stage product candidates into clinical development;

regulatory approvals for any product candidates that successfully complete clinical trials;

any pre-commercialization activities to establish sales, marketing and distribution capabilities for any product candidates for which

we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties;

expand and protect our intellectual property portfolio;

milestone, royalty or other payments due under any future in-license or collaboration agreements.

meet the requirements and

demands of being a public company;

expand our operational,

financial and management systems and increase personnel to support our operations;

hire additional clinical,

quality control, medical, scientific and other technical personnel to support our clinical operations;

advance our clinical-stage

product candidate PF614 through clinical development;

advance our preclinical

stage product candidates into clinical development;

seek regulatory approvals

for any product candidates that successfully complete clinical trials;

undertake any pre-commercialization

activities to establish sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory

approval in regions where we choose to commercialize our products on our own or jointly with third parties;

maintain, expand and protect

our intellectual property portfolio;

make milestone, royalty

or other payments due under any future in-license or collaboration agreements.

Pharmaceutical

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require substantial additional funding.

If we are unable raise capital when needed, we could be forced to delay, reduce or terminate

If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate

our product discovery and development programs or commercialization efforts.

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future need for additional funding depends on many factors, including:

scope, progress, results and costs of researching and developing our current product candidates, as well as other additional product

candidates we may develop and pursue in the future, including the costs related to preclinical and clinical development of the product;

timing of, and the costs involved in, obtaining marketing approvals for our product candidates and any other additional product candidates

we may develop and pursue in the future;

number of future product candidates that we may pursue and their development requirements;

to receipt of regulatory approval, the costs of commercialization activities for our product candidates, to the extent such costs

are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing,

distribution and manufacturing capabilities;

to receipt of regulatory approval, the amount of revenue, if any, received from commercial sales of our product candidates or any

other additional product candidates we may develop and pursue in the future;

extent to which we in-license or acquire rights to other products, product candidates or technologies;

ability to establish collaboration arrangements for the development of our product candidates on favorable terms, if at all;

on financing, our headcount growth and associated costs as we expand our research and development and establishes a commercial infrastructure;

costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights, including

enforcing and defending intellectual property related claims;

costs of operating as a public company.

the scope, progress, results

and costs of researching and developing our current product candidates, as well as other additional product candidates we may develop

and pursue in the future, including the costs related to preclinical and clinical development of the product;

the timing of, and the

costs involved in, obtaining marketing approvals for our product candidates and any other additional product candidates we may develop

and pursue in the future;

the number of future product

candidates that we may pursue and their development requirements;

subject to receipt of regulatory

approval, the costs of commercialization activities for our product candidates, to the extent such costs are not the responsibility

of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing

capabilities;

subject to receipt of regulatory

approval, the amount of revenue, if any, received from commercial sales of our product candidates or any other additional product

candidates we may develop and pursue in the future;

the extent to which we

in-license or acquire rights to other products, product candidates or technologies;

our ability to establish

collaboration arrangements for the development of our product candidates on favorable terms, if at all;

dependent on financing,

our headcount growth and associated costs as we expand our research and development and establishes a commercial infrastructure;

the costs of preparing,

filing and prosecuting patent applications, maintaining and protecting our intellectual property rights, including enforcing and

defending intellectual property related claims;

the costs of operating

as a public company.

change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly

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experience other issues that may delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and

insufficiency

of our financial and other resources to complete the necessary clinical trials and preclinical studies;

or inconclusive results from our clinical trials, preclinical studies or the clinical trials of others for product candidates that

are similar to ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon

product-related

adverse events experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs

or therapeutic biologics similar to our product candidates;

in submitting an Investigational New Drug application, or IND, or comparable foreign applications or delays or failure in obtaining

the necessary approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial

once commenced;

imposed by the FDA, the European Medicines Agency, or EMA, or comparable foreign regulatory authorities regarding the scope or design

of our clinical trials;

effectiveness of our product candidates during clinical trials;

than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our

clinical trials;

in enrolling subjects in clinical trials;

drop-out rates of subjects from clinical trials;

supply or quality of product candidates or other materials necessary for the conduct of our clinical trials;

than anticipated clinical trial or manufacturing costs;

FDA, EMA or comparable regulatory authority inspection and review of a clinical trial site;

of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise

meet their contractual obligations in a timely manner, or at all;

FDA, EMA or comparable regulatory authority inspection and review of manufacturing facilities or inability of those facilities to

maintain a compliance status acceptable to the FDA, EMA or comparable regulatory authorities;

and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around

clinical testing generally or with respect to our therapies in particular;

interpretations of data by the FDA, EMA and comparable foreign regulatory authorities.

inability to demonstrate

to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective;

insufficiency of our financial

and other resources to complete the necessary clinical trials and preclinical studies;

negative or inconclusive

results from our clinical trials, preclinical studies or the clinical trials of others for product candidates that are similar to

ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program;

product-related adverse

events experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic

biologics similar to our product candidates;

delays in submitting an

Investigational New Drug application, or IND, or comparable foreign applications or delays or failure in obtaining the necessary

approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced;

conditions imposed by the

FDA, the European Medicines Agency, or EMA, or comparable foreign regulatory authorities regarding the scope or design of our clinical

poor effectiveness of our

product candidates during clinical trials;

better than expected performance

of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials;

delays in enrolling subjects

in clinical trials;

high drop-out rates of

subjects from clinical trials;

inadequate supply or quality

of product candidates or other materials necessary for the conduct of our clinical trials;

greater than anticipated

clinical trial or manufacturing costs;

unfavorable FDA, EMA or

comparable regulatory authority inspection and review of a clinical trial site;

failure of our third-party

contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual

obligations in a timely manner, or at all;

unfavorable FDA, EMA or

comparable regulatory authority inspection and review of manufacturing facilities or inability of those facilities to maintain a

compliance status acceptable to the FDA, EMA or comparable regulatory authorities;

delays and changes in regulatory

requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally

or with respect to our therapies in particular;

varying interpretations

of data by the FDA, EMA and comparable foreign regulatory authorities.

product candidates will require additional, time-consuming development efforts prior to commercial sale, including preclinical studies,

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the timing of such potential achievement of the respective milestones to vary considerably from our estimates, including:

available capital resources or capital constraints we experience;

rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling

conflicts with participating clinicians and collaborators;

ability to identify and enroll patients who meet clinical trial eligibility criteria;

receipt of approvals by the FDA and other regulatory authorities and the timing thereof;

actions, decisions or rules issued by regulators;

ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates;

efforts of our collaborators with respect to the commercialization of our product candidates;

securing of, costs related to, and timing issues associated with, product manufacturing as well as sales and marketing activities.

our available capital resources

or capital constraints we experience;

the rate of progress, costs

and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating

clinicians and collaborators;

our ability to identify

and enroll patients who meet clinical trial eligibility criteria;

our receipt of approvals

by the FDA and other regulatory authorities and the timing thereof;

clinical outcomes;

other actions, decisions

or rules issued by regulators;

our ability to access sufficient,

reliable and affordable supplies of materials used in the manufacture of our product candidates;

the efforts of our collaborators

with respect to the commercialization of our product candidates;

the securing of, costs

related to, and timing issues associated with, product manufacturing as well as sales and marketing activities.

we fail to achieve any announced milestones in the timeframes we expect, the development and commercialization of our product candidates

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other qualified personnel in the future.

currently only have seven full-time employees, one part-time employee and one consultant and we expect to add additional employees.

future success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial,

technical, clinical and regulatory personnel.

currently have eight full-time employees and two part-time employees.

Our future success also depends on our ability to identify, attract,

hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory personnel.

for such individuals, particularly in the United States, is intense, and we may not be able to hire sufficient personnel to support our

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that may inhibit our efforts to commercialize our product candidates on our own include:

inability to recruit and retain effective sales and marketing personnel;

inability of sales personnel to obtain access to or persuade physicians to prescribe any future products;

lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies

with more extensive product lines;

costs and expenses associated with creating an independent sales and marketing organization.

our inability to recruit

and retain effective sales and marketing personnel;

the inability of sales

personnel to obtain access to or persuade physicians to prescribe any future products;

the lack of complementary

products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive

product lines;

unforeseen costs and expenses

associated with creating an independent sales and marketing organization.

respect to our existing and future product candidates, we may choose to collaborate with third parties that have direct sales forces

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current and future product candidates could fail to receive regulatory approval for many reasons, including the following:

FDA or comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials;

may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate

is safe and effective for our proposed indication;

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

authorities for approval;

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

FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical

data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA to the FDA

or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;

FDA or comparable foreign regulatory authorities may find deficiencies with the manufacturing processes of third-party manufacturers

with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering

our clinical data insufficient for approval.

the FDA or comparable foreign

regulatory authorities may disagree as to the design or implementation of our clinical trials;

we may be unable to demonstrate

to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for our

proposed indication;

the results of clinical

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

we may be unable to demonstrate

that a product candidate’s clinical and other benefits outweigh its safety risks;

the FDA or comparable foreign

regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies;

the data collected from

clinical trials of our product candidates may not be sufficient to support the submission of an NDA to the FDA or other submission

or to obtain regulatory approval in the United States, the European Union or elsewhere;

the FDA or comparable foreign

regulatory authorities may find deficiencies with the manufacturing processes of third-party manufacturers with which we contract

for clinical and commercial supplies;

the approval policies or

regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data

insufficient for approval.

lengthy approval process as well as the unpredictability of clinical trial results may result in us failing to obtain regulatory approval

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candidates we develop, including:

or institutional review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical

trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

may not reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to

extensive negotiation and may vary significantly among different CROs and trial sites;

may experience challenges or delays in recruiting principal investigators or study sites to lead our clinical trials;

number of subjects or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment

in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any

given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical

trials at a higher rate than we anticipate;

third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail

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

may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in

regulatory requirements or guidance, which we may be required to resubmit to an IRB and regulatory authorities for re-examination;

or other reviewing bodies may find deficiencies with or subsequently find fault with the manufacturing processes or facilities of

third-party manufacturers with which we enter into agreement for clinical and commercial supplies, or the supply or quality of any

product candidate or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate

or not available at an acceptable cost, or we may experience interruptions in supply;

potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in

a manner rendering our clinical data insufficient for approval.

regulators, or institutional

review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct

or continue a clinical trial at a prospective or specific trial site;

we may not reach agreement

on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and

may vary significantly among different CROs and trial sites;

we may experience challenges

or delays in recruiting principal investigators or study sites to lead our clinical trials;

the number of subjects

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

trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may

be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at

a higher rate than we anticipate;

our third-party contractors,

including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory

requirements or meet their contractual obligations to us in a timely manner, or at all;

we may have to amend clinical

trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or

guidance, which we may be required to resubmit to an IRB and regulatory authorities for re-examination;

regulators or other reviewing

bodies may find deficiencies with or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers

with which we enter into agreement for clinical and commercial supplies, or the supply or quality of any product candidate or other

materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable

cost, or we may experience interruptions in supply;

the potential for approval

policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our

clinical data insufficient for approval.

or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring

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may experience difficulties in patient enrollment in our clinical trials for a variety of factors, including:

patient eligibility criteria defined in the protocol;

size of the patient population required for analysis of the trial’s primary endpoints;

proximity of patients to study sites;

design of the trial;

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

clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate

being studied in relation to other available therapies, including any new drugs that may be approved for the indications that we

are investigating;

ability to obtain and maintain patient consents;

risk that patients enrolled in clinical trials will drop out of the trials before completion.

the patient eligibility

criteria defined in the protocol;

the size of the patient

population required for analysis of the trial’s primary endpoints;

the proximity of patients

to study sites;

the design of the trial;

our ability to recruit

clinical trial investigators with the appropriate competencies and experience;

competing clinical trials

and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied

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

our ability to obtain and

maintain patient consents;

the risk that patients

enrolled in clinical trials will drop out of the trials before completion.

addition, our clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as

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and execute our business plan.

The Investor Notes contain such restrictions including a pledge of substantially all of our tangible and

intangible assets, including our intellectual property.

Certain warrants we have issued contain such restrictions including a pledge of substantially all of our

tangible and intangible assets, including our intellectual property.

we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations, strategic alliances or

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that we would otherwise prefer to develop and market ourselves.

we are unable to regain and maintain compliance with the listing standards of Nasdaq, our common stock could be delisted and may become

subject to “penny stock” rules, which could have a material adverse effect on the liquidity of our common stock, the ability

of investors to sell their shares and our ability to raise funding.

November 14, 2024, we received notice from Nasdaq stating that we had demonstrated compliance with the $2.5 million stockholders’

equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2024.

On December 20, 2024, we received notice from

Nasdaq that we had regained compliance with the bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

As of September 30,

2025, we were not in compliance with that stockholders’ equity requirement but on November 14, 2025, we raised additional capital

and our stockholders’ equity then exceeded the requirement.

On February 25, 2026, we received notice from Nasdaq that we are no

longer in compliance with the bid price requirement because the price of our common stock has remained below $1.00 for more than 30 consecutive

business days.

We have until August 24, 2026, and possibly longer, to regain compliance with the bid price requirement.

no assurance that we will be able to regain and/or maintain compliance with such Nasdaq Listing Rules and our common stock could be delisted.

de-listing of our common stock on Nasdaq could have a material adverse effect on us, including on our ability to raise capital through

alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors,

suppliers, customers and employees and fewer business development opportunities.

Upon any delisting, our common stock could become subject

to the regulations of the SEC relating to the market for penny stocks.

Penny stocks are securities with a price of less than $5.00 per

share unless (i) the securities are traded on a “recognized” national exchange or (ii) the issuer has net tangible assets

less than $2,000,000 (if the issuer has been in continuous operation for at least three years) or $5,000,000 (if in continuous operation

for less than three years), or with average annual revenues of less than $6,000,000 for the last three years.

procedures applicable to penny stocks requires a broker-dealer to (i) obtain from the investor information concerning his financial situation,

investment experience and investment objectives;

(ii) reasonably determine, based on that information, that transactions in penny stocks

are suitable for the investor and that the investor has sufficient knowledge and experience as to be reasonably capable of evaluating

the risks of penny stock transactions;

(iii) provide the investor with a written statement setting forth the basis on which the broker-dealer

made the determination in (ii) above;

and (iv) receive a signed and dated copy of such statement from the investor, confirming that it

accurately reflects the investor’s financial situation, investment experience and investment objectives.

The regulations applicable

to penny stocks may severely affect the market liquidity for our common stock and could limit the ability of stockholders to sell their

common stock in the secondary market.

are a smaller reporting company within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure

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of our common stock to decline.

we are unable to maintain compliance with the listing standards of Nasdaq, our common stock could be delisted and may become subject

to “penny stock” rules, which could have a material adverse effect on the liquidity of our common stock, the ability of investors

to sell their shares and our ability to raise funding.

November 14, 2024, we received notice from Nasdaq stating that we had demonstrated compliance with the $2.5 million stockholders’

equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2024.

On December 20, 2024, we received notice from

Nasdaq that we had regained compliance with the bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

There can be no assurance

that we will be able to maintain compliance with such Nasdaq Listing Rules and our common stock could be delisted.

de-listing of our common stock on Nasdaq could have a material adverse effect on us, including on our ability to raise capital through

alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors,

suppliers, customers and employees and fewer business development opportunities.

Upon any delisting, our common stock could become subject

to the regulations of the SEC relating to the market for penny stocks.

Penny stocks are securities with a price of less than $5.00 per

share unless (i) the securities are traded on a “recognized” national exchange or (ii) the issuer has net tangible assets

less than $2,000,000 (if the issuer has been in continuous operation for at least three years) or $5,000,000 (if in continuous operation

for less than three years), or with average annual revenues of less than $6,000,000 for the last three years.

procedures applicable to penny stocks requires a broker-dealer to (i) obtain from the investor information concerning his financial situation,

investment experience and investment objectives;

(ii) reasonably determine, based on that information, that transactions in penny stocks

are suitable for the investor and that the investor has sufficient knowledge and experience as to be reasonably capable of evaluating

the risks of penny stock transactions;

(iii) provide the investor with a written statement setting forth the basis on which the broker-dealer

made the determination in (ii) above;

and (iv) receive a signed and dated copy of such statement from the investor, confirming that it

accurately reflects the investor’s financial situation, investment experience and investment objectives.

The regulations applicable

to penny stocks may severely affect the market liquidity for our common stock and could limit the ability of stockholders to sell their

common stock in the secondary market.

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