What changed in this filing

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Item 1A. Risk Factors

2026-03-13 compared with 2025-06-02 · 315 added, 353 removed, 2037 unchanged (25% of the section changed)

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If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate our product or other operations.

has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable

As of December 31, 2024, the Company had cash of approximately $0.6 million, a working capital deficit of approximately

$17.3 million and an accumulated deficit of approximately $115.7 million.

We has incurred substantial operating losses since inception and expects

to continue to incur significant operating losses for the foreseeable future.

As of December 31, 2025, we had cash of approximately

$5.2 million, a working capital deficit of approximately $3.1 million and an accumulated deficit of approximately $131.2 million.

as of March 11, 2026, our cash balance was approximately $3.6 million.

We estimate, as of the date of this Report, that

our current cash balance is not sufficient to fund operations through the end of May 2026.

We believe that we will need to raise substantial

additional capital to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the

Company’s working capital needs and business activities, including the commercialization of Proclarix, which is still subject to

further successful development and commercialization activities within certain jurisdictions.

Management also intends to secure additional required

funding through equity or debt financings if available.

In December 2024, the Company began utilizing the ELOC entered into in October

2024 (see Note 9) on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints.

However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under

the ELOC will not be sufficient to sustain operations.

In addition, there are currently no other commitments in place for further financing

nor is there any assurance that such financing will be available to the Company on favorable terms, if at all.

This creates significant

uncertainty whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix.

If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization

of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient

to sustain operations and meet its obligations, or, if its required to, file for bankruptcy.

These conditions raise substantial doubt about

the Company’s ability to continue as a going concern for a period of time within one year following the date of this Report.

future capital requirements will depend on many factors, including:

our current cash balance is not sufficient to fund operations for one year from the date of issuance of these consolidated financial statements.

We believe that we will need to raise substantial additional capital to fund our continuing operations, satisfy existing and future obligations

and liabilities, and otherwise support the Company’s working capital needs and business activities, including the commercialization

of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions.

We have entered into Series D and Series E PIPE financings with certain

investors in September 2025 and October 2025, respectively which provided us additional cash flow to support our near-term operations.

While such capital raises may enable us to sustain current operations and meet existing obligations, we continue to generate recurring

net operating losses and have not yet established sustained positive cash flows to support our strategic growth initiatives.

Such initiatives

include the commercialization of Proclarix and our development and commercialization of future product candidates.

These factors raise

substantial doubt on our ability to continue as a going concern for one year from the date of issuance of our consolidated financial statements

for the financial year ended December 31, 2025.

Our management plans for funding our operations

include generating product revenue from sales of Proclarix, which is currently subject to further successful development and commercialization

activities within certain jurisdictions.

Our management also intends to pursue additional equity or debt financing to support operations

and strategic initiatives.

However, other than the outstanding Committed Equity Facility, there are currently no committed sources of

financing, and there is no assurance that additional funding will be available on favorable terms, if at all.

This uncertainty raises

significant concern about our ability to sustain operations and execute our strategic initiatives.

If additional capital is not secured,

we may need to curtail clinical trials, development, and commercialization efforts, and take further measures to reduce expenses to conserve

Our future capital requirements will depend on

many factors, including:

the costs of future development and commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and other products for which we have received or will receive marketing approval;

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in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.

We owe a significant amount of money to

Veru, which funds we do not have.

Veru may take action against us to enforce its rights to payment in the future, which could have a material

adverse effect on us and our operations.

Due to recent financial constraints, the Company

may be unable to timely pay amounts due to Veru, from whom we purchased ENTADFI in April 2023.

We may not have sufficient funds to pay

amounts due to Veru in the near term, if at all, including but not limited to $10 million, $5 million of which was due on April 19, 2024

and is subject to certain forbearance terms, and $5 million of which was due on September 30, 2024 and was subject to certain forbearance

On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance period was further extended

until June 30, 2025 by limited waiver on March 31, 2025 and April 24, 2025, with respect to, among other things, our inability to pay

amounts due on April 19, 2024, and on September 19, 2024, Veru agreed to forbear its rights and remedies until June 30, 2025 with respect

to, among other things, our inability to pay amounts due on September 30, 2024.

In addition, on November 26, 2024, the Company and Veru

entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due date for payment of applicable

Company cash receipt payments generated in October 2024 in consideration for an increase in payments to be made to Veru out of future

financing and strategic transactions through June 30, 2025.

However, Veru may take future action against us, including filing legal proceedings

against us seeking amounts due and interest accrued or attempting to terminate its relationship with us.

If Veru were to take legal action

against us, we may be forced to scale back our business plan and/or seek bankruptcy protection.

We may be subject to litigation and damages

for our failure to pay amounts due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.

In light of (i) the time and resources needed to continue pursuing

commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of

ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets.

is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction

of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

We plan to seek funding to support our operations

and to pay amounts due to Veru, through a combination of equity offerings, debt financing or other capital sources, including potential

collaborations, licenses, sales, and other similar arrangements, which may not be available on favorable terms, if at all.

additional equity or debt securities, if accomplished, may result in dilution to our stockholders.

Furthermore, any revenue or financing

proceeds that we are required to pay to Veru will detract from our ability to use such funds to support our operations.

Our current liabilities are significant,

and if those to whom we owe accounts payable, such as Veru or other vendors, were to demand payment, we would be unable to pay.

and if those to whom we owe accounts payable, were to demand payment, we would be unable to pay.

As of December 31, 2025, we had total current

liabilities of approximately $9.1 million, including accounts payable of approximately $1.8 million, accrued expenses of approximately

$0.9 million, and approximately $9.3 million (net of discount) related to the notes payable due to Veru.

As of the same date, we had cash

of only $0.6 million.

In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s

cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist

with the potential sale or other transaction of the ENTADFI assets.

There is currently no plan to resume commercialization of ENTADFI,

and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy

our inventory of the product.

We plan to seek funding to support our operations.

We have also concurrently reduced our liabilities by

entering into a settlement agreement, dated January 15, 2025, with IQVIA, Inc.

concerning potential termination payments, whereby we recorded

an adjustment of approximately ($0.9) million in accounts payable.

However, the level of our current liabilities may make it more difficult

for us to obtain adequate financing on favorable terms, if at all.

If those to whom these payments are due were to demand immediate payment,

as they are entitled to do, and we are not able to make the required payments, we would be subject to liability if our creditors chose

to enforce their rights, which could result in our bankruptcy and insolvency.

Under such a scenario, our assets would be distributed to

our creditors leaving nothing to be distributed to our stockholders.

$0.3 million, derivative liabilities of approximately $7.0 million, and approximately $0.03 million related to contingent warrant liabilities.

As of the same date, we had cash of only $5.2 million.

In September 2025, we completed a Series D financing, which satisfied all amounts

due under the Veru notes.

In October 2025, we completed a Series E financing, and plan to seek additional funding as necessary to support

our operations and growth initiatives.

However, the level of our current liabilities may make it more difficult for us to obtain adequate

financing on favorable terms, if at all.

If those to whom these payments are due were to demand immediate payment, as they are entitled

to do, and we are not able to make the required payments, we would be subject to liability if our creditors chose to enforce their rights,

which could result in our bankruptcy and insolvency.

Under such a scenario, our assets would be distributed to our creditors leaving nothing

to be distributed to our stockholders.

Risks Related to the Commercialization of our Product

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Our business currently depends heavily on the

successful commercialization of our product.

successful commercialization of our product Proclarix.

We cannot be certain that our product will be successfully commercialized.

The manufacturing,

safety, efficacy, labeling, sale, marketing, and distribution of our product are, and will remain, subject to comprehensive regulation

by the FDA and similar foreign regulatory authorities.

The success of our product will depend on several additional factors, including:

manufacturing, safety, efficacy, labeling, sale, marketing, and distribution of our product are, and will remain, subject to comprehensive

regulation by the FDA and similar foreign regulatory authorities.

The success of our product will depend on several additional factors,

establishing commercial manufacturing capabilities;

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our product, which would materially harm our business, financial condition, and results of operations.

In addition, we may not successfully commercialize

We or our collaboration partners in any potential commercial marketing efforts of our product may not be successful in achieving

widespread patient or physician awareness or acceptance of this product.

Also, we may be subject to pricing pressures from competitive

products or from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize

Any failure to commercialize our product could have a material adverse effect on our future revenue and our business

Obtaining and maintaining regulatory approval

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if we file, we may not receive necessary approvals to commercialize our product in any market.

Company shareholders may not realize a benefit from the ENTADFI

or Proteomedix acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.

If the Company is unable to realize the full strategic and financial

benefits previously anticipated from the recent ENTADFI and Proteomedix acquisitions, our shareholders may experience a dilution of their

ownership interests in our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the

extent the Company is able to realize only part of the strategic and financial benefits previously anticipated from the transactions.

In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway

and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the

potential sale or other transaction of the ENTADFI assets.

There is currently no plan to resume commercialization of ENTADFI, and as such,

if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory

of the product.

Company shareholders may not realize a benefit from the Proteomedix

acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.

If the Company is unable to realize the full strategic

and financial benefits previously anticipated from acqusition, our shareholders may experience a dilution of their ownership interests

in our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the Company

is able to realize only part of the strategic and financial benefits previously anticipated from the transactions.

In light of (i) the

time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness,

the Company abandoned commercialization of ENTADFI and no longer holds inventory of ENTADFI.

There is currently no plan to resume commercialization

Disruptions to or significantly increased

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our expectations, could harm our business.

We may fail or elect not to commercialize

We may not successfully commercialize our product.

We or our collaboration partners in any potential commercial marketing efforts of our product may not be successful in achieving widespread

patient or physician awareness or acceptance of this product.

Also, we may be subject to pricing pressures from competitive products or

from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our product.

Any failure to commercialize our product could have a material adverse effect on our future revenue and our business.

In light of (i) the time and resources needed

to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned

commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI

There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other

transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

If we fail to commercialize Proclarix, our business,

financial condition, results of operations and prospects may be materially adversely affected and our reputation in the industry and in

the investment community would likely be damaged.

We are dependent on third parties, including

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from a few major customers.

For the year ended December 31, 2025, 100% of our development service revenue, 100% of our other revenue,

and 92% of our product sales revenue came from Immunovia, and 5% and 3% of our remaining product sales revenue came from Zentrum fur Labormedizi

and Cambridge, respectively.

For the year ended December 31, 2024, 100% of our development service revenue came from Immunovia, and 73%

and 18% of our product sales revenue came from LabCorp and Cambridge, respectively.

For the year ended December 31, 2023, we generated

100% of our revenue from one customer, in the context of a partnership with Immunovia AB (Sweden).

In 2022, Immunovia AB partnered with

Proteomedix to leverage Proteomedix’s research and development capabilities and to advance their research and development efforts.

There are inherent risks whenever a large percentage

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in the future, and we may experience difficulties in managing this growth.

As of May 30, 2025, we had 5 full-time and 2 subcontracted

We will need to increase the size of our organization in order to support our continued commercialization of our product.

our commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales,

marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not be adequate to

support this future growth.

As of March 11, 2026, we had 2 full-time and

6 subcontracted employees.

We will need to increase the size of our organization in order to support our continued commercialization

of our product.

As our commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing,

sales, marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not be adequate

to support this future growth.

Future growth would impose significant added responsibilities on members of management, including:

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As a result, the patents and patent

applications owned or licensed to us may not provide us with sufficient rights to exclude others from commercializing methods/products

similar or identical to ours.

applications owned or licensed may not provide us with sufficient rights to exclude others from commercializing methods/products similar

or identical to ours.

Even if we believe that the patents involved are eligible for certain (and time-limited) patent term extensions,

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any FDA marketing approval of any product candidates we may develop, one or more of the U.S.

patents licensed to us may be eligible for

limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory

review process.

A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product

approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing

it may be extended.

However, we may not be granted an extension because of, for example, failing to exercise due diligence during the

testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant

patents, or otherwise failing to satisfy applicable requirements.

patents licensed may be eligible for limited

patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.

The Hatch-Waxman

Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.

A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only

one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may

However, we may not be granted an extension because of, for example, failing to exercise due diligence during the testing

phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents,

or otherwise failing to satisfy applicable requirements.

Moreover, the applicable time period or the scope

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included drugs expected to increase over the coming years and incorporate drugs in Medicare Parts B and D.

The enhanced ACA premium subsidies that were extended

through 2025 under the Inflation Reduction Act are still in effect, even though they were set to expire at the end of 2025.

efforts are ongoing, but Congress has not yet succeeded in securing a continuation of enhanced ACA exchange subsidies beyond 2025, and

the outcome remains uncertain.

Meanwhile, the Medicare drug price negotiation program created by the IRA is now being implemented:

has negotiated lower prices for an initial set of high-cost Part D drugs effective January 1, 2026, and additional drugs have been selected

for subsequent years, with negotiation expanding in 2027 and beyond to include more Part D and later Part B drugs

Our employees may engage in misconduct or other

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often been unrelated or disproportionate to the operating performance of the issuer.

For example, on September 27, 2024 and December 24,

For example, on February 13, 2025 and May 13, 2025,

the closing price of our common stock on Nasdaq was $46.07 and $6.46, respectively, and daily trading volume on these days was approximately

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These broad market fluctuations may adversely affect the trading price of our common stock.

In particular, a proportion of our common stock may be traded by short sellers which may put pressure on the supply and demand for our

common stock, further influencing volatility in its market price.

particular, a proportion of our common stock may be traded by short sellers which may put pressure on the supply and demand for our common

stock, further influencing volatility in its market price.

Additionally, these and other external factors have caused and may continue

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costs and divert our management’s attention from other business concerns, which could seriously harm our business.

We may have violated Section 13(k) of the

Exchange Act (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.

Section 13(k) of the Exchange Act

provides that it is unlawful for a company that has a class of securities registered under Section 12 of the Exchange Act to,

directly or indirectly, including through any subsidiary, extend or maintain credit in the form of a personal loan to or for any of its

directors or executive officers.

In the fiscal year ended December 31, 2022 and the nine months ended September 30, 2023,

we paid certain expenses of our former Chief Executive Officer and Chairman of the Board, which may be deemed to be personal loans made

by us to our former Chief Executive Officer and Chairman of the Board that are not permissible under Section 13(k) of the Exchange Act.

Specifically, after a review completed by the Audit Committee, it was determined that our former

CEO and an accounting employee charged certain personal expenses on their corporate credit cards that were not recorded as related party

The aggregate amount of such unauthorized charges ranged from approximately (i) $257,000 to $405,000 for all of 2022, (ii)

$86,000 to $122,000 for the quarter ended March 31, 2023 and (iii) $79,000 to $150,000 for the quarter ended June 30, 2023.

The accounting

employee was also the CEO’s assistant and had roles in the Company’s system of internal control over financial reporting,

including controls relating to the Company’s corporate credit cards.

Issuers that are found to have violated Section 13(k) of

the Exchange Act may be subject to civil sanctions, including injunctive remedies and monetary penalties, as well as criminal sanctions.

The imposition of any of such sanctions on us could have a material adverse effect on our business, financial position, results of operations

or cash flows.

If we fail to maintain

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submitted to stockholders for approval.

As of May 30, 2025, our officers and directors,

together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 2,695,931

shares of our common stock, which in the aggregate represents approximately 6.08% of the outstanding shares of our common stock.

result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted

to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate

of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.

These actions may be taken even if they are opposed by other stockholders.

This concentration of ownership may also have the effect of

delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could

prevent our stockholders from receiving a premium for their shares.

Some of these persons or entities who make up our principal stockholders

may have interests different from yours.

As of March 11, 2026, our officers and directors, together with holders

of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 557,604 shares of our common

stock, which in the aggregate represents approximately 15.6% of the outstanding shares of our common stock.

As a result, if some of these

persons or entities act together, they will have the ability to exercise significant influence over matters submitted to our stockholders

for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate of Incorporation and

Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.

These actions may

be taken even if they are opposed by other stockholders.

This concentration of ownership may also have the effect of delaying or preventing

a change of control of our company or discouraging others from making tender offers for our shares, which could prevent our stockholders

from receiving a premium for their shares.

Some of these persons or entities who make up our principal stockholders may have interests

different from yours.

There can be no assurance that we will be

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depends on our ability to comply with Nasdaq’s continued listing requirements.

On January 24, 2025, the Company received a letter

from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company’s Common Stock

from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The Nasdaq

Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum

Bid Price Rule”).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq provided the Company with 180 calendar days to regain

compliance with the Minimum Bid Price Rule.

On April 14, 2025, Nasdaq issued a further notice

to the Company that it determined that the Company’s securities had a closing bid price of $0.10 or less for ten consecutive trading

Accordingly, the Company is subject to the provisions under Nasdaq Listing Rule 5810(c)(3)(A)(iii).

As a result, unless the Company

timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”), trading of the Common Stock would be suspended

at the opening of business on April 23, 2025, and a Form 25-NSE would be filed with the SEC, which would remove the Company’s securities

from listing and registration on Nasdaq.

On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a stay of

The Panel’s decision about the stay request is still pending as of the date these financials were filed.

On April 24, 2025, the Company received an additional

deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing

Rule 5250(c)(1) given the Company’s failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31,

2024, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.

As the Company was

already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar days from the date of the

Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension of the Company’s securities

pending the Panel’s decision.

The Company submitted a stay request on or before May 1, 2025.

On May 20, 2025, the Company received an additional

deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing

Rule 5250(c)(1) given the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,

and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.

The Company had seven calendar

days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension of the Company’s

securities pending the Panel’s decision.

On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a

stay of suspension.

The Panel’s decision about the stay request is still pending as of the date these financials were filed.

There are no assurances that the Panel will grant

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our stock price to decline.

we or our existing stockholders, directors and officers sell, or indicate an intent to sell,

substantial amounts of our common stock or securities convertible into our common stock in

the public market after contractual lock-up and other legal restrictions on resale lapse,

the trading price of our common stock could decline significantly and could decline below

the initial public offering price.

We have outstanding 44,358,422 shares of common stock

as of the date hereof, assuming no exercise of outstanding options or warrants, are or will

be freely tradable, without restriction, in the public market.

If our existing stockholders

sell substantial amounts of our common stock in the public market, or if the public perceives

that such sales could occur, this could have an adverse impact on the market price of our

common stock, even if there is no relationship between such sales and the performance of

our business.

We have previously registered 1,450,000 shares of common stock under our equity

compensation plans.

These shares can be freely sold in the public market upon issuance, subject

to volume limitations applicable to affiliates and lock-up agreements.

If we or our existing stockholders, directors and officers sell, or indicate

an intent to sell, substantial amounts of our common stock or securities convertible into our common stock in the public market after

contractual lock-up and other legal restrictions on resale lapse, the trading price of our common stock could decline significantly and

could decline below the initial public offering price.

We have outstanding 3,584,245 shares of common stock as of the date hereof, assuming

no exercise of outstanding options or warrants, are or will be freely tradable, without restriction, in the public market.

If our existing

stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales could occur,

this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the

performance of our business.

We have previously registered 17,058 shares of common stock under our equity compensation plans.

can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and lock-up agreements.

Upon issuance, the 23 shares subject to outstanding

options under our stock option plan and the shares reserved for future issuance under our stock option plan will become eligible for

sale in the public market in the future, subject to certain legal and contractual limitations.

options under our stock option plan and the shares reserved for future issuance under our stock option plan will become eligible for sale

in the public market in the future, subject to certain legal and contractual limitations.

If our existing stockholders sell substantial

amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse

impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact

on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

The issuance or conversion of securities would result in significant

dilution in the equity interest of existing shareholders and adversely affect the market price of the securities.

The issuance or conversion of common shares or other securities convertible

into common shares would result significant dilution in the equity interest of existing shareholders and adversely affect the market price

of the common shares.

In particular, the Company is party to an ELOC,

pursuant to which it may offer and sell, from time to time at its sole discretion, up to $25.0 million of newly issued Common Stock, subject

to certain limitations.

As of December 31, 2024 and May 30, 2025, the Company has sold approximately 2,757,933 shares and 33,256,563 shares

under the ELOC Purchase Agreement for aggregate proceeds of approximately $0.9 million and $5.3 million, respectively, totaling 36,014,496

shares sold under the ELOC Purchase Agreement for gross proceeds of approximately $6.2 million.

In January 2025, there were 3,492,067

shares that were settled bringing the total sold shares to approximately 6,250,000 shares under the ELOC Purchase Agreement.

Additionally,

as of May 30, 2025, an aggregate of 2,130 Series C Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate

of $1.71 million.

An additional amount of $150,531 is due to the PIPE Series C investors for 120 Series C preferred shares that remain

due from the most recent ELOC draw.

These 120 shares remain subject to future redemption.

If we fail to maintain an effective system

of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory

sanctions, harm our business and operating results and cause the trading price of our stock to decline.

Effective internal controls required under Section

404 of the Sarbanes-Oxley Act are necessary for us to provide reliable financial reports and effectively prevent fraud.

If we cannot provide

reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed.

We have discovered, and may

in the future discover, areas of our internal controls that need improvement.

We cannot be certain that the measures we have taken or

intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future.

Any failure to

implement the required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,

harm our business and operating results or cause us to fail to meet our reporting obligations.

Inferior internal controls could also harm

our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the

trading price of our stock.

The issuance or conversion of common shares or

other securities convertible into common shares would result significant dilution in the equity interest of existing shareholders and

adversely affect the market price of the common shares.

In particular, the Company is party to an ELOC, pursuant to which it may

offer and sell, from time to time at its sole discretion, up to $25.0 million of newly issued Common Stock, subject to certain limitations.

As of December 31, 2025, the Company has sold approximately 661,762 shares under the ELOC Purchase Agreement for aggregate proceeds of

approximately $7.1 million.

In addition, as of December 31, 2025, 7 shares of Series C Preferred Stock were outstanding from the original

issuance of 3,499 shares of Series C Preferred stock to institutional investors, after (i) the redemption of 1,369 shares of Series C

Preferred Stock for aggregate consideration of $1.71 million, (ii) the conversion of 1,920 shares of Series C Preferred Stock into shares

of common stock, and (iii) the exchange of 203 shares of Series C Preferred Stock into 244 shares of Series D Preferred Stock.

As of December

31, 2025, 16,325 shares of Series D Preferred Stock and 7,813 shares of Series E Preferred stock, respectively, were outstanding.

as of March 11, 2026, at the election of their holders, 1,916 shares of Series D Preferred Stock had converted into 1,852,715 shares of

common stock and 132 shares of Series E Preferred Stock had converted into 176,363 shares of common stock.

We are an “emerging growth company”

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Failure in, or security breaches or incidents

impacting, our information technology or storage systems could significantly disrupt our operations and our research and development efforts.

Our ability to execute our business strategy will

depend, in part, on the continued and uninterrupted performance of our information technology, or IT, systems, which support our operations,

including at our proposed clinical laboratories.

We are dependent on our IT systems for many aspects of our business, including our needs

to retain and store our confidential and proprietary business information and to receive and process test orders, securely store patient

health records and deliver the results of our tests.

The integrity and protection of our own data, and that of our customers and employees,

is critical to our business.

The regulatory environment governing information, security and privacy and data protection laws is increasingly

demanding and continues to evolve.

IT systems are vulnerable to damage from a variety of sources, including telecommunications or network

failures, cyberattacks (including ransomware attacks) and other malicious human acts from criminal hackers, hacktivists, state-sponsored

impacting, our information technology or storage systems could significantly disrupt our operations and our research and development

Our ability to execute our business strategy

will depend, in part, on the continued and uninterrupted performance of our information technology, or IT, systems, which support our

operations, including at our proposed clinical laboratories.

We are dependent on our IT systems for many aspects of our business, including

our needs to retain and store our confidential and proprietary business information and to receive and process test orders, securely

store patient health records and deliver the results of our tests.

The integrity and protection of our own data, and that of our customers

and employees, is critical to our business.

The regulatory environment governing information, security and privacy and data protection

laws is increasingly demanding and continues to evolve.

IT systems are vulnerable to damage from a variety of sources, including telecommunications

or network failures, cyberattacks (including ransomware attacks) and other malicious human acts from criminal hackers, hacktivists, state-sponsored

intrusions and other attacks, industrial espionage and employee malfeasance, breaches and incidents due to employee error or negligence,

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for six months and is then automatically deleted.

High-profile security breaches and incidents at

other companies and in government agencies have increased in recent years, particularly in the healthcare sector, and security industry

High-profile security breaches and incidents

at other companies and in government agencies have increased in recent years, particularly in the healthcare sector, and security industry

experts and government officials have warned about the risks of hackers and cyber-attacks targeting businesses such as ours.

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collect, process and prepare company financial information;

provide information about our tests and other patient and healthcare provider education and outreach efforts through our website;

provide information about our tests and other patient and healthcare

provider education and outreach efforts through our website;

manage the administrative aspects of our business and damage our reputation.

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Further, third-party service providers who support

our operations, and our independent contractors, consultants, collaborators, and service providers also may suffer interruptions and disruptions

of systems and other breaches, incidents, or other compromises of their IT systems or data that they process or maintain for us, which

may lead to any of the foregoing.

We and our third-party service providers may not have the resources or technical sophistication to anticipate

or prevent all cyberattacks or other sources of security breaches or incidents, and we or they may face difficulties or delays in identifying

and responding to cyberattacks and data security breaches and incidents.

In addition, the interpretation and application of consumer or

health related data security, privacy and protection laws in the United States, Europe and elsewhere are often uncertain, contradictory

and in flux, such as in the area of international transfers of personal data.

Complying with these various laws and satisfying healthcare

providers’ and patients’ evolving expectations with respect to data protection, could cause us to incur substantial costs

or require us to change our business practices and compliance procedures in a manner adverse to our business.

our operations, and our independent contractors, consultants, collaborators, and service providers also may suffer interruptions and

disruptions of systems and other breaches, incidents, or other compromises of their IT systems or data that they process or maintain

for us, which may lead to any of the foregoing.

We and our third-party service providers may not have the resources or technical sophistication

to anticipate or prevent all cyberattacks or other sources of security breaches or incidents, and we or they may face difficulties or

delays in identifying and responding to cyberattacks and data security breaches and incidents.

In addition, the interpretation and application

of consumer or health related data security, privacy and protection laws in the United States, Europe and elsewhere are often uncertain,

contradictory and in flux, such as in the area of international transfers of personal data.

Complying with these various laws and satisfying

healthcare providers’ and patients’ evolving expectations with respect to data protection, could cause us to incur substantial

costs or require us to change our business practices and compliance procedures in a manner adverse to our business.

We do not maintain insurance policies for cybersecurity-related

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at the time of issuance by our board of directors without further action by stockholders.

The terms of any series of preferred stock may

include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion

The terms of any series of preferred stock

may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion

and redemption rights and sinking fund provisions.

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and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:

provide the board of directors with the ability to alter the bylaws without stockholder approval;

provide the board of directors with the ability to alter the bylaws

without stockholder approval;

place limitations on the removal of directors;

establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

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

establish advance notice requirements for nominations for election

to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

provide that vacancies on the board of directors may be filled by a

majority of directors in office, although less than a quorum.

These provisions, alone or together, could delay

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foreseeable future.

A possible “short squeeze” due

to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

A possible “short squeeze”

due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

Investors may purchase our common stock to hedge

existing exposure in our common stock or to speculate on the price of our common stock.

Speculation on the price of our common stock may

involve long and short exposures.

To the extent aggregate short exposure exceeds the number of shares of our common stock available for

purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders

of our common stock.

Those repurchases may in turn dramatically increase the price of our common stock until investors with short exposure

are able to purchase additional common shares to cover their short position.

This is often referred to as a “short squeeze.”

A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance, or prospects

of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common

stock may decline.

Risks Related to Pending Business Combination

If completed, the Ocuvex Business Combination may not achieve

its intended results and may result in us assuming unanticipated liabilities.

We entered into the Ocuvex LOI with the expectation

that the Ocuvex Business Combination would result in various benefits and growth opportunities.

Achieving the anticipated benefits of

the transaction is subject to a large number of risks and uncertainties, including our ability to raise the substantial capital required

for the Ocuvex Business Combination.

Additionally, the success of the Ocuvex Business Combination depends on, among other things, the

accuracy of our assessment of the assets associated with the acquired assets, operating costs and various other factors.

These assessments

are necessarily inexact.

As a result, we may not recover the purchase price for the acquisition or recognize an acceptable return on sales.

The transactions contemplated by the Ocuvex

LOI are subject to conditions that may not be satisfied on a timely basis or at all.

Failure to complete the transactions contemplated

by the Ocuvex LOI could have material and adverse effects on us.

Completion of the Ocuvex Business Combination

is subject to a number of conditions, including the accuracy of the parties’ representations in the transactions as contemplated

by the Ocuvex LOI.

Such conditions, some of which are beyond our control, may not be satisfied or waived in a timely manner or at all

and therefore make the completion and timing of the completion of the Ocuvex Business Combination uncertain.

In addition, the Ocuvex LOI

contains certain termination rights for both parties, which if exercised will also result in the Ocuvex Business Combination not being

If the transactions contemplated by the Ocuvex

LOI are not completed, our business may be adversely affected and, without realizing any of the benefits of having completed the Ocuvex

Business Combination, we will be required to pay our costs relating to the Ocuvex Business Combination, such as legal, accounting, and

financial advisory fees.

In addition, time and resources committed by our management to matters relating to the Ocuvex Business Combination

could otherwise have been devoted to pursuing other beneficial opportunities;

and the market price of our common stock could be impacted

to the extent that the current market price reflects a market assumption that the Ocuvex Business Combination will be completed.

We will be subject to business uncertainties

while the Ocuvex Business Combination is pending, which could adversely affect our business.

It is possible that certain persons with whom

we have a business relationship may delay certain business decisions relating to us, or seek to terminate, change or renegotiate their

relationships with us, in connection with the pendency of the Ocuvex Business Combination.

This could negatively affect our revenues,

earnings and cash flows, as well as the market price of our common stock, regardless of whether the Ocuvex Business Combination is completed.

We expect to incur significant transaction

costs in connection with the Ocuvex Business Combination.

Speculation on the price of our common stock

may involve long and short exposures.

To the extent aggregate short exposure exceeds the number of shares of our common stock available

for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery

to lenders of our common stock.

Those repurchases may in turn dramatically increase the price of our common stock until investors with

short exposure are able to purchase additional common shares to cover their short position.

This is often referred to as a “short

squeeze.” A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance,

or prospects of our company and once investors purchase the shares of common stock necessary to cover their short position the price

of our common stock may decline.

Risks Related to Pending Share Exchange

could fail to complete the Realbotix Transactions, or the Realbotix Transactions may be completed on different terms.

There can be no assurance that the Realbotix Transactions

will be completed, or if completed, that they will be completed on the same or similar terms to those set out in our previous disclosure.

The Realbotix Transactions are subject to the satisfaction of a number of conditions precedent, some of which are outside our control,

which include, among others, performance by Simulacra and Realbotix of their respective obligations and covenants in the Share Exchange

If these conditions are not satisfied (or waived) or the Realbotix Transactions are not completed for any other reason, our

stockholders will not receive the consideration contemplated in the Share Exchange Agreement.

If the Realbotix Transactions are not completed,

our ongoing business may be adversely affected as a result of the costs (including opportunity costs) incurred in respect of pursuing

the Realbotix Transactions, and we could experience negative reactions from the financial markets, which could cause a decrease in the

market price of our Common Stock, particularly if the current market price reflects market assumptions that the Realbotix Transactions

will be completed or completed on certain terms.

We may also experience negative reactions from our employees and there could be negative

impact our ability to attract future business opportunities.

Failure to complete the Realbotix Transactions or a change in the terms of

the Realbotix Transactions could each have a material adverse effect on our business, financial condition and results of operations.

issuance of securities would result in significant dilution in the equity interest of existing stockholders and adversely affect the

marketplace of our Common Stock.

The issuance or conversion of Common Stock or other

securities convertible into Realbotix Common Stock in connection with the Realbotix Transactions would result in significant dilution

in the equity interest of our existing stockholders and adversely affect the market price of our Common Stock.

In addition, future issuances

of, or conversions of, securities may result in significant dilution to our existing stockholders, which could adversely impact your investment.

Our stockholders may not realize a benefit

from the acquisition of Realbotix commensurate with the ownership dilution they will experience in connection with the Realbotix Transactions

contemplated by the Share Exchange Agreement.

If we are unable to realize the full strategic

and financial benefits currently anticipated from the Realbotix Transactions, our stockholders may experience a dilution of their ownership

interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent we are able to

realize only part of the strategic and financial benefits currently anticipated from the Realbotix Transactions.

The Realbotix Transactions

may pose integration challenges which could result in management and business disruptions, any of which could harm our results of operation,

business prospects, and impair the value of the Realbotix Transactions to our stockholders.

The failure to successfully integrate the

businesses of us and Realbotix in the expected timeframe would adversely affect our future results.

Our ability to successfully integrate our operations

and those of Realbotix will depend, in part, on our ability to realize the anticipated benefits from the Realbotix Transactions.

are not able to achieve the stated objectives, the anticipated benefits of the Realbotix Transactions may not be realized fully, or at

all, or may take longer to realize than expected, and the value of our Common Stock may be adversely affected.

In addition, the integration

of our and Realbotix’s respective businesses will be a time-consuming and expensive process.

Proper planning and effective and timely

implementation will be critical to avoid any significant disruption to our operations.

It is possible that the integration process could

result in the loss of key employees, the disruption of our business or the identification of inconsistencies in standards, controls, procedures

and policies that adversely affect our ability to maintain relationships with customers, suppliers, distributors, creditors or lessors,

or to achieve the anticipated benefits of the Realbotix Transactions.

Delays encountered in the integration process could have a material

adverse effect on our operating results and financial condition, including the value of our Common Stock.

The pending Realbotix Transactions may divert

the attention of our management.

The pending Realbotix Transactions could cause

the attention of our management to be diverted from the day-to-day operations.

These disruptions could be exacerbated by a delay in the

completion of the Realbotix Transactions and could have an adverse effect on our business, operating results or prospects regardless of

whether the Realbotix Transactions are ultimately completed.

Unexpected market disruptions may cause

major losses for us not anticipated under the Share Exchange Agreement.

We may incur major losses in the event of disrupted

markets and other extraordinary events in which market behavior diverges significantly from historically recognized patterns, which may

offset any potential benefits achieved under the Share Exchange Agreement.

The risk of loss in such events may be compounded by the fact

that, in disrupted markets, many positions become illiquid, making it difficult or impossible to close out positions against which markets

Market disruptions caused by unexpected political, military and terrorist events, or other factors, may from time to time

cause dramatic losses for us.

Risks associated with changes in the technology

Realbotix operates in a competitive industry characterized

by rapid technological change and evolving industry standards.

Realbotix’s ability to attract new customers to its business, and

generate revenue from existing customers will depend largely on its ability to anticipate industry standards and trends, respond to technological

advances in its industry, and keep pace with technological developments and customers’ increasingly sophisticated needs.

of any enhancement of Realbotix’s products or new related applications will depend on several factors, including the timely completion

and market acceptance of the products.

Realbotix’s services are expected to embody

complex technology that may not meet those standards, changes and preferences.

Realbotix’s ability to design, develop and commercially

launch products depends on a number of factors, including, but not limited to, its ability to design and implement solutions and services

at an acceptable cost and quality, its ability to attract and retain skilled technical employees, the availability of critical components

from third parties, and its ability to successfully complete the development of the products in a timely manner.

There is no guarantee

that Realbotix will be able to respond to market demands.

If Realbotix is unable to effectively respond to technological changes or fails

or delays to develop services in a timely and cost-effective manner, Realbotix may be unable to recover our development expenses which

could negatively impact sales, profitability and the continued viability of its business.

may be unable to protect Realbotix’s intellectual property.

Realbotix’s commercial success depends to a

significant degree upon its ability to develop new or improved technologies, instruments, and services, and to obtain patents, where appropriate,

or other intellectual property rights or statutory protection for these technologies and products in Canada and the United States.

devoting resources to the research and development of proprietary technology, Realbotix, may not be able to develop new technology that

is patentable or protectable.

Further, patents issued to Realbotix, if any, could be challenged, held invalid or unenforceable, or be

circumvented and may not provide Realbotix with necessary or sufficient protection or a competitive advantage.

Competitors and other third

parties may be able to design around Realbotix’s intellectual property or develop technology similar to Realbotix’s products

that is not within the scope of such intellectual property.

Realbotix’s inability to secure its indirectly owned, intellectual property

rights may have a materially adverse effect on its business and results of operations.

The business of Realbotix is exposed to

cybersecurity risks.

Cyber incidents can result from deliberate attacks

or unintentional events, and may arise from internal sources (e.g., employees, contractors, suppliers and operational risks) or external

sources (e.g., nation states, terrorists, hacktivists, competitors and acts of nature).

Cyber incidents include unauthorized access to

information systems and data (e.g., through hacking or malicious software) for purposes of misappropriating or corrupting data or causing

operational disruption.

Cyber incidents also may be caused in a manner that does not require unauthorized access, such as causing denial-of-service

attacks on websites (e.g., efforts to make network services unavailable to intended users).

A cyber incident that affects Realbotix might

cause disruptions and adversely affect their respective business operations and might also result in violations of applicable law (e.g.,

personal information protection laws), each of which might result in potentially significant financial losses and liabilities, regulatory

fines and penalties, reputational harm, and reimbursement and other compensation costs to Realbotix.

In addition, substantial costs might

be incurred to investigate, remediate, and prevent cyber incidents.

We expect to incur significant transaction costs

in connection with the Realbotix Transactions

We expect to incur a number of non-recurring costs

associated with negotiating and completing the Ocuvex Business Combination.

associated with negotiating and completing the Realbotix Transaction.

These fees and costs have been, and will continue to be, substantial

and, in many cases, will be borne by us whether or not the Ocuvex Business Combination is completed.

and, in many cases, will be borne by us whether or not the Realbotix Transaction is completed.

A substantial majority of our non-recurring

expenses will consist of transaction costs related to the Ocuvex Business Combination and include, among others, fees paid to financial,

legal, accounting and other advisors.

We will continue to assess the magnitude of these costs, and we may incur additional unanticipated

The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Ocuvex Business

Combination is not completed, could have an adverse effect on our financial condition and operating results.

expenses will consist of transaction costs related to the Realbotix Transactions and include, among others, fees paid to financial, legal,

accounting and other advisors.

We will continue to assess the magnitude of theses costs, and we may incur additional unanticipated costs.

The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Realbotix Transaction

is not completed, could have an adverse effect on our financial condition and operating results.

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What changed 10-K

Item 1A. Risk Factors