What changed in this filing

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Item 1A. Risk Factors

2026-06-01 compared with 2025-04-15 · 37 added, 58 removed, 1884 unchanged (5% of the section changed)

24 unchanged sentences

we reported a net loss of $19.4 million and $17.4 million, respectively.

As of December 31, 2024, we had an accumulated deficit of $66.2

As of December

31, 2025, we had an accumulated deficit of $87.1 million.

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

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programs or commercialization efforts.

expect our existing cash as of December 31, 2024 will enable us to fund our operating expenses through and capital expenditure requirements

for at least twelve months from the date of this Annual Report on Form 10-K;

however, our existing cash will not be sufficient to complete

Our existing cash will not be sufficient to complete

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

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

of December 31, 2024, we had federal net operating loss, or NOLs, carryforwards of approximately $30.0 million.

Our NOLs generated in

tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

and will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused and be unavailable to offset

future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017 may be carried forward

indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will conform

to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a corporation

undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership of its

equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes

to offset its post-change income may be limited.

of December 31, 2025, we had federal net operating loss, or NOLs, carryforwards of approximately $44.2

Our NOLs generated in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years

under applicable U.S.

tax laws, and will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused

and be unavailable to offset future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December

31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent

various states will conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize

its applicability.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions

of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change,

by value, in the ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards

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

Related to the Development and Regulatory Approval of Our Product Candidate

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will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.

of April 11, 2025, we had 4 full-time employees and 4 part-time employees.

We will need to grow the size of our organization in order

to support our continued development and potential commercialization of our product candidate.

As our development and 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

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

of May 26, 2026, we had 4 full-time employees and 9 part-time employees.

We will need to grow the size of our organization in

order to support our continued development and potential commercialization of our product candidate.

As our development and

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,

our clinical trials effectively;

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requiring stockholder approval.

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

52% of our outstanding shares of common stock.

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

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

or substantially all of our assets.

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

affairs of our company.

of May 26, 2026, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own

approximately 51% of our outstanding shares of common stock.

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

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

or sale of all or substantially all of our assets.

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

management and affairs of our company.

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

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if any, of our share price.

are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging

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

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

reporting requirements that are applicable to other public companies that are not “emerging growth companies” including not

being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations

regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding

advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we intend to take advantage of the extended transition

period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.

In other words,

an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise

apply to private companies.

We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and

our stock price may be more volatile.

We may take advantage of these reporting exemptions until we are no longer an “emerging growth

company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in

which we have total annual gross revenues of $1.07 billion or more;

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

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

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

debt during the previous three years;

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

may be at risk of securities class action litigation.

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In connection with management’s assessment

of internal controls over financial reporting for the quarter ended September 30, 2020, we identified a material weakness due to inadequate

of internal controls over financial reporting for the year ended December 31, 2025 and all prior periods, we identified a material weakness due to inadequate

segregation of duties within our accounting processes due to limited personnel and insufficient written policies and procedures for accounting,

IT and financial reporting and record keeping.

IT and financial reporting and record keeping, lack of accounting system for financial reporting/bookkeeping and software

for stock awards, and insufficient policies and procedures for processing and approving employee expense reports.

Although we are developing a plan to remediate the material weaknesses, we cannot assure

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

What changed 10-K

Item 1A. Risk Factors